Robotic surgery and heated chemotherapy for gastric cancer with peritoneal spread
A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
This study is testing if a new robotic surgery combined with heated chemotherapy can help people with advanced stomach cancer that has spread to the abdominal lining feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05753306 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the effectiveness of robotic cytoreduction combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has metastasized to the peritoneum. The approach utilizes minimally invasive robotic surgery to reduce tumor burden while administering heated chemotherapy directly into the abdominal cavity during the procedure. This method aims to enhance recovery, reduce complications, and improve survival rates for patients with limited peritoneal metastasis. The trial includes patients aged 18 to 80 with specific eligibility criteria related to their cancer status and overall health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed gastric adenocarcinoma and limited peritoneal metastasis.
Not a fit: Patients with extensive peritoneal metastasis or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery times and survival rates for patients with gastric cancer that has spread to the peritoneum.
How similar studies have performed: Other studies have shown promising results with robotic surgery and HIPEC for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Travis E Grotz, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.