Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
Conditions
Brief summary
This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES: I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration. SECONDARY OBJECTIVES: I. To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis. OUTLINE: Patients undergo hyperthermic intraperitoneal chemotherapy (HIPEC) comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy. After completion of study treatment, patients are followed up within 4 weeks, and then every 6 months for 5 years.
Interventions
DRUGCisplatin
Given intraperitoneally
DRUGHyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
DRUGMitomycin
Given intraperitoneally
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
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
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction * Leukocytes \>= 3,000/uL * Absolute neutrophil count \>= 1,500/uL * Platelets \>= 60,000/Ul * Serum creatinine =\< 1.5 mg/dL * Distant metastatic disease of peritoneum may be visualized on imaging: * Positive peritoneal cytology * Carcinomatosis on diagnostic laparoscopy or laparotomy * Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC
Exclusion criteria
* Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, lung) * Infections such as pneumonia or wound infections that would preclude protocol therapy * Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence * Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure * Subjects deemed unable to comply with study and/or follow-up procedures * Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Date of diagnosis to date of death or last follow-up | Overall survival from the date of diagnosis in subjects with stage IV gastric cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clavien-Dindo Surgical Complications | 90-days from surgery | 90-day surgical complications graded according to an accepted classification scale (Clavien-Dindo) Classification of Surgical Complications Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V: Death of a patient |
Countries
United States
Participant flow
Recruitment details
Phase II single arm trial at a single clinic and hospital from September 2016 to March 2019.
Pre-assignment details
Exclusion criteria included stage IV disease outside of the peritoneum
Participants by arm
| Arm | Count |
|---|---|
| Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy cytoreduciton, gastrectomy, and intraperitoneal chemotherapy | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 58 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 20 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 20 |
| other Total, other adverse events | 15 / 20 |
| serious Total, serious adverse events | 7 / 20 |
Outcome results
Primary
Overall Survival
Overall survival from the date of diagnosis in subjects with stage IV gastric cancer
Time frame: Date of diagnosis to date of death or last follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | Overall Survival | 22.1 Months |
Secondary
Clavien-Dindo Surgical Complications
90-day surgical complications graded according to an accepted classification scale (Clavien-Dindo) Classification of Surgical Complications Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V: Death of a patient
Time frame: 90-days from surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | Clavien-Dindo Surgical Complications | Grade I and II | 15 events |
| Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | Clavien-Dindo Surgical Complications | Grade III | 6 events |
| Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy | Clavien-Dindo Surgical Complications | Grade IV | 1 events |