NCT05753306 Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
| NCT ID | NCT05753306 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Gastric Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-04-20 |
| Primary Completion | 2030-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-04-20 with a primary completion date of 2030-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Travis E Grotz, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT05753306 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Gastric Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05753306 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05753306 currently recruiting?
Yes, NCT05753306 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT05753306 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05753306 clinical trial?
NCT05753306 is sponsored by Mayo Clinic. The principal investigator is Travis E Grotz, MD at Mayo Clinic in Rochester. The trial plans to enroll 40 participants.