Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum
Conditions
Brief summary
This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.
Interventions
DRUGCisplatin
Given via HIPEC
PROCEDUREComputed Tomography
Undergo CT scan or PET/CT
PROCEDUREGastrectomy
Undergo robotic gastrectomy
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
PROCEDUREPositron Emission Tomography
Undergo PE/CT
OTHERQuestionnaire Administration
Complete questionnaire
DRUGPaclitaxel
Given via HIPEC
DRUGHyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Restricted to 18 to 80 years of age * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomas * Absolute neutrophil count \>= 1,500 / uL * Platelets \>= 50,000 / Ul * Serum creatinine \<= 1.5 mg / dL * Adequate nutritional status (Albumin \>= 3.5) * Metastasis confined to the peritoneum: * Positive peritoneal cytology * Peritoneal metastasis on diagnostic laparoscopy * Peritoneal metastasis on imaging * Response to systemic chemotherapy defined as at least one of the following: * Reduction (\>= 30%) in standardized uptake value (SUV) max \[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\] * Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (\>= 20% decrease in the longest diameter of target lesion) RECIST criteria * Reduction ( \>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology * Reduction ( \>= 30%) in serum tumor markers CEA or CA 19-9 * Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeon deems high likelihood for a complete cytoreduction * Body Mass Index (BMI) =\< 35 kg/m\^2
Exclusion criteria
* Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc) * Malignant ascites at time of study enrollment * Comorbidities that would preclude protocol therapy * 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 |
|---|---|---|
| Hospital length of stay | Up to 30 days post-surgery | Recorded as number of days in hospital following surgery. |
| 30 day readmission rate | Up to 30 days post-surgery | Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery |
| Adverse Events | Up to 30 days post surgery | Assessed by Clavien-Dindo Classification (grade 1-5, grade 1 being least severe and grade 5 being death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperative | Recorded as the time from incision to close |
| Opioid consumption | Up to 3 years | Assessed by morphine milligram equivalents during hospitalization and post-surgical recovery. |
| Nursing reported pain scores | Up to 3 years | As recorded (mean and max) during hospitalization and post-surgery follow-up visits |
| Recurrence-Free Survival (RFS) | Up to 3 years | Assessed from the date of gastrectomy and hyperthermic intraperitoneal chemotherapy (HIPEC). Patterns of tumor recurrence will be assessed by reviewing routine surveillance imaging. |
| Overall Survival (OS) | Up to 3 years | Defined as the time from gastrectomy and HIPEC until death due to any cause. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORTravis E Grotz, MD
Mayo Clinic in Rochester
Outcome results
None listed