Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cisplatin, Computed Tomography, Gastrectomy, Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
Overview
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
- Drug Cisplatin
Given via HIPEC - Procedure Computed Tomography
Undergo CT scan or PET/CT - Procedure Gastrectomy
Undergo robotic gastrectomy - Procedure Magnetic Resonance Imaging
Undergo MRI - Procedure Positron Emission Tomography
Undergo PE/CT - Other Questionnaire Administration
Complete questionnaire - Drug Paclitaxel
Given via HIPEC - Drug Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
Primary outcome measures
- Hospital length of stay [Time frame: Up to 30 days post-surgery]
- 30 day readmission rate [Time frame: Up to 30 days post-surgery]
- Adverse Events [Time frame: Up to 30 days post surgery]
Secondary outcome measures (5)
- Operative time [Time frame: Intraoperative]
- Opioid consumption [Time frame: Up to 3 years]
- Nursing reported pain scores [Time frame: Up to 3 years]
- Recurrence-Free Survival (RFS) [Time frame: Up to 3 years]
- Overall Survival (OS) [Time frame: Up to 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05753306 · 22-004680 · NCI-2023-00431 · 22-004680