Gastric Adenocarcinoma, Esophagogastric Junction, Gastric Cancer
Conditions
Keywords
Surgical Resection, Progression Free Survival, Gastroesophageal junction (Siewert III) adenocarcinoma
Brief summary
Background: \- Gastric cancer is a common and serious cancer. Standard treatment is chemotherapy drugs. Researchers want to see if a new treatment helps. It is surgical removal of the cancer and heated chemotherapy delivered to the abdominal cavity called Hyperthermic intraperitoneal chemotherapy (HIPEC). Objective: \- To test if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve survival in people with gastric cancers. Eligibility: \- People ages 18 and older with gastric cancer who can have most tumors surgically removed Design: * Participants will be screened with: * Medical history * Physical exam * Blood, urine, and heart tests * Scans * Tissue sample from previous surgery * Endoscopy with biopsy: A tube with a camera goes through the mouth and into the stomach. It and takes a sample of stomach tissue. Participants may get medicine to make them drowsy. * Laparoscopy: Small cuts are made in the abdomen. A thin tube with a light and camera is inserted into the abdomen. Participants sleep through the procedure. Participants will stay in the hospital. They will have: * Surgery to remove as many tumors as possible. * HIPEC for 60 minutes: Two thin tubes are put into the abdomen. Two chemotherapy drugs are given through one tube. They are drained out through another at a temperature a few degrees above normal body temperature. Another drug is given in a vein. * Recovery for 7-21 days: Participants will have tubes in their stomach and bladder and intravenous (IVs) for a few days. They will get pain medicine, IV fluids, antibiotics, and blood transfusions as needed. * Participants will have visits every few months for 3 years, then one a year. Visits include physical exam, blood tests, and scans. They also include dietary assessment and questions.
Detailed description
Background: * An estimated 24,590 cases of gastric adenocarcinoma are diagnosed annually in the United States (U.S.). * The peritoneal surface is a site of metastasis found often at time of diagnosis and is a common (40%) site of recurrence. * Laparoscopy with peritoneal lavage and cytopathologic analysis is a staging modality that can identify a subset of patients with microscopic peritoneal metastasis prior to consideration for definitive surgical therapy. * Intraperitoneal chemotherapy has been employed in advanced gastric cancers and as an adjuvant with an associated improvement in survival in systematic reviews. Objectives: \- Determine the overall survival in patients with cytology-positive gastric cancer treated with Hyperthermic intraperitoneal chemotherapy (HIPEC) and gastrectomy. Eligibility: * Histologically confirmed adenocarcinoma of the stomach. * Cytopathologic evidence of peritoneal carcinomatosis. * Medically fit for systemic chemotherapy, HIPEC and gastrectomy. Design: \- Single arm, Phase II study of HIPEC and gastrectomy.
Interventions
PROCEDURESurgery
Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate
DRUGCisplatin
Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity
DRUGMitomycin C
Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity
DRUGSodium Thiosulfate
Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours.
PROCEDURETumor Biopsy
At screening, baseline (if not done at screening) and operation (as clinically indicated).
DIAGNOSTIC_TESTCT C/A/P
At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up.
DIAGNOSTIC_TESTPET-CT
At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up.
DIAGNOSTIC_TESTMRI
If computed tomography (CT) contraindicated.
DIAGNOSTIC_TESTEKG
At screening and baseline (if not done at screening).
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: * Patients must have histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert I-III) adenocarcinoma confirmed by the Laboratory of Pathology, national Cancer Institute (NCI). * Must have received systemic chemotherapy, minimum 3 months or maximum 6 months, prior to enrollment * Systemic therapy should consist of at least fluoropyrimidine-based and/or platinum-based chemotherapy * Trastuzumab may be added for human epidermal growth factor receptor 2 (HER2)-neu over-expressing cancers as clinically indicated * Last dose of chemotherapy within 8 weeks of enrollment with recovery to Grade 1 from chemotherapy-related toxicities * Documentation of chemotherapy administration must be obtained * Subradiographic and/or cytopathologic evidence of peritoneal carcinomatosis found at staging laparoscopy. * Documentation of cytopathologic diagnosis of malignant peritoneal cytology in the absence of disseminated peritoneal disease must be obtained. If cytologic analysis reveals atypical cells of undetermined significance, a repeat lavage with cytopathologic analysis will be performed and must demonstrate evidence of malignancy. * Limited peritoneal involvement found at staging laparoscopy or on final pathology that is deemed completely resectable is permitted * Age \>18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \<2 * Patients must have normal organ and marrow function as defined below: * hemoglobin \> 8.0 g/dL * absolute neutrophil count greater than or equal to 1,000/mcL * platelets greater than or equal to100,000/mcL * total bilirubin within normal institutional limits * Aspartate aminotransferase (AST)Serum glutamic-oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT)Serum glutamic-pyruvic transaminase (SGPT) less than or equal to 2.5 X institutional upper limit of normal * creatinine \< 1.5 mg/dl * estimated glomerular filtration rate (GFR) (creatinine clearance) greater than or equal to 60 mL/min/1.73 m\^2. * Physiologically able to undergo heated intraperitoneal chemotherapy (HIPEC) and gastrectomy * No history of malignancy within 2 years of enrollment except for basal cell carcinoma of the skin, squamous cell skin cancer or carcinoma in situ of the cervix. * Ability of subject to understand and the willingness to sign a written informed consent document * Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors.
Exclusion criteria
* Patients who are receiving any investigational agents * Disseminated extra-peritoneal or solid organ metastases * Includes carcinomatosis associated with clinically or radiographically evident ascites (greater than 500cc) --Excludes greater omentum and ovarian metastases * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because HIPEC and gastrectomy have not been studied in pregnant women and has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infant's secondary to treatment of the mother with HIPEC and gastrectomy, breastfeeding should be discontinued if the mother is treated on this study. * Human immunodeficiency virus (HIV)-positive patients may be considered for this study only after consultation with a National Institute of Allergy and Infectious Diseases (NIAID) physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 53.7 months | OS is defined as the median amount of time a participant survives after therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months | 6 months, 12 months and 18 months | Intraperitoneal progression free survival is defined as the median amount of time a participant survives from date of operation (hyperthermic intraperitoneal chemotherapy (HIPEC) and gastrectomy) without intraperitoneal disease progression after treatment. Intraperitoneal progression is defined as new, large volume ascites with or without associated peritoneal nodularity or thickening determined by radiographic imaging, cytopathology or histopathology. |
| Extra-peritoneal Disease-free Survival | 48.9 months | Extra-peritoneal disease-free survival is defined as the median amount of time a participant survives from date of surgery to the date of first observation of progressive disease at sites other than the peritoneal surface (e.g., liver, intra-abdominal lymph nodes, abdominal wall soft tissues, and any other solid organs) determined by radiographic imaging (i.e., computed tomography, magnetic resonance imaging, and/or positron emission tomography). |
| Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Up to 1646 days | The number of treatment related serious and/or non-serious adverse events by type related to research treatments was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Document adverse events from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Surgery: Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate
Cisplatin: Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity
Mitomycin C: Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity
Sodium Thiosulfate: Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours.
Tumor Biopsy: At screening, baseline (if not done at screening) and operation (as clinically indicated).
Computed tomography chest/abdomen and pelvis (CT C/A/P): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up.
Positron emission tomography-computed tomography (PET-CT): At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up.
Magnetic resonance imaging (MRI): If computed tomography (CT) contraindicated.
Electrocardiogram (EKG): At screening and baseline (if not done at screening). | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 2 |
Baseline characteristics
| Characteristic | Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 47.81 years STANDARD_DEVIATION 13.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 23 / 27 |
| other Total, other adverse events | 23 / 27 |
| serious Total, serious adverse events | 10 / 27 |
Outcome results
Primary
Overall Survival (OS)
OS is defined as the median amount of time a participant survives after therapy.
Time frame: 53.7 months
Population: 25/27 participants were analyzed because 2 were deemed ineligible.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Overall Survival (OS) | 11.96 Months |
Secondary
Extra-peritoneal Disease-free Survival
Extra-peritoneal disease-free survival is defined as the median amount of time a participant survives from date of surgery to the date of first observation of progressive disease at sites other than the peritoneal surface (e.g., liver, intra-abdominal lymph nodes, abdominal wall soft tissues, and any other solid organs) determined by radiographic imaging (i.e., computed tomography, magnetic resonance imaging, and/or positron emission tomography).
Time frame: 48.9 months
Population: 25/27 participants were analyzed because 2 were deemed ineligible.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Extra-peritoneal Disease-free Survival | 48.9 Months |
Secondary
Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months
Intraperitoneal progression free survival is defined as the median amount of time a participant survives from date of operation (hyperthermic intraperitoneal chemotherapy (HIPEC) and gastrectomy) without intraperitoneal disease progression after treatment. Intraperitoneal progression is defined as new, large volume ascites with or without associated peritoneal nodularity or thickening determined by radiographic imaging, cytopathology or histopathology.
Time frame: 6 months, 12 months and 18 months
Population: 25/27 participants were analyzed because 2 were deemed ineligible.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months | 6 months | 0.9 Months |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months | 12 months | 0.83 Months |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months | 18 months | 0.83 Months |
Secondary
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type
The number of treatment related serious and/or non-serious adverse events by type related to research treatments was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Up to 1646 days
Population: 2/27 participants were deemed ineligible prior to treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Colitis | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hyperkalemia | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Aspartate aminotransferase | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypernatremia | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Confusion | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypertension | 2 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Abdominal pain | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypoalbuminemia | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Cough | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypocalcemia | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Aspiration | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypokalemia | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Creatinine increased | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hyponatremia | 2 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Alkaline phosphatase increased | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypophosphatemia | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Cystitis noninfective | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypotension | 4 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Atelectasis | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypothermia | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Dehydration | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypoxia | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Activated partial thromboplastin time prolonged | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Infections and infestations-other | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Depressed level of consciousness | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Insomnia | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Atrial fibrillation | 4 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Intraoperative urinary injury | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Depression | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Lung infection | 3 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Anemia | 12 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Lymphocyte count decreased | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Diarrhea | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Malaise | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Atrial flutter | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Mediastinal infection | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Disseminated intravascular coagulation | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Metabolism and nutrition disorders other | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Abdominal infection | 2 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Nausea | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Dizziness | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Neutrophil count decreased | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Back pain | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Oral pain | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Duodenal fistula | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pain | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Anorexia | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pain in extremity | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Dyspnea | 5 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pericardial effusion | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Bladder perforation | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Platelet count decreased | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Edema limbs | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pleural effusion | 9 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Acute kidney injury | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pleural infection | 2 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Esophageal anastomotic leak | 2 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pneumothorax | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Bloating | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Productive cough | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Esophagitis | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Renal and urinary disorders-other | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Anxiety | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Respiratory failure | 5 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Fatigue | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Respiratory, thoracic and mediastinal disorders-other | 4 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Blood bilirubin increased | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Sepsis | 5 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Fever | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Serum amylase increased | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Acidosis | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Sinus bradycardia | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Gastrointestinal anastomotic leak | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Sinus tachycardia | 3 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | CPK increased | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Small intestinal obstruction | 3 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Headache | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Sore throat | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Ascites | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Upper gastrointestinal hemorrhage | 2 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hematuria | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Urinary tract infection | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Chest wall pain | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Vaginal anastomotic leak | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hiccups | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Vomiting | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Alanine aminotransferase increased | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Weight loss | 2 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hyperglycemia | 0 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | White blood cell decreased | 1 adverse events |
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | abdominal distension | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | White blood cell decreased | 5 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | abdominal distension | 3 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Abdominal infection | 4 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Abdominal pain | 18 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Acidosis | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Activated partial thromboplastin time prolonged | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Acute kidney injury | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Alanine aminotransferase increased | 15 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Alkaline phosphatase increased | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Anemia | 69 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Anorexia | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Anxiety | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Ascites | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Aspartate aminotransferase | 21 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Aspiration | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Atelectasis | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Atrial fibrillation | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Atrial flutter | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Back pain | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Bladder perforation | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Bloating | 3 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Blood bilirubin increased | 8 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | CPK increased | 3 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Chest wall pain | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Colitis | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Confusion | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Cough | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Creatinine increased | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Cystitis noninfective | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Dehydration | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Depressed level of consciousness | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Depression | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Diarrhea | 5 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Disseminated intravascular coagulation | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Dizziness | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Duodenal fistula | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Dyspnea | 4 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Edema limbs | 6 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Esophageal anastomotic leak | 4 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Esophagitis | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Fatigue | 3 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Fever | 12 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Gastrointestinal anastomotic leak | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Headache | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hematuria | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hiccups | 5 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hyperglycemia | 3 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hyperkalemia | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypernatremia | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypertension | 8 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypoalbuminemia | 30 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypocalcemia | 7 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypokalemia | 4 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hyponatremia | 3 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypophosphatemia | 48 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypotension | 15 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypothermia | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Hypoxia | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Infections and infestations-other | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Insomnia | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Intraoperative urinary injury | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Lung infection | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Lymphocyte count decreased | 44 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Malaise | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Mediastinal infection | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Metabolism and nutrition disorders other | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Nausea | 11 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Neutrophil count decreased | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Oral pain | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pain | 10 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pain in extremity | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pericardial effusion | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Platelet count decreased | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pleural effusion | 4 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pleural infection | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Pneumothorax | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Productive cough | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Renal and urinary disorders-other | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Respiratory failure | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Respiratory, thoracic and mediastinal disorders-other | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Sepsis | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Serum amylase increased | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Sinus bradycardia | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Sinus tachycardia | 11 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Small intestinal obstruction | 0 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Sore throat | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Upper gastrointestinal hemorrhage | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Urinary tract infection | 2 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Vaginal anastomotic leak | 1 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Vomiting | 8 adverse events |
| Non-Serious | Number of Treatment Related Serious and/or Non-serious Adverse Events by Type | Weight loss | 6 adverse events |
Other Pre-specified
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Document adverse events from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days
Population: 25/27 participants were analyzed because 2 were deemed ineligible.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 23 Participants |