Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study

Mayo Clinic

Status and phase

Enrolling

Phase 2

Conditions

Metastatic Malignant Neoplasm in the Peritoneum

Gastroesophageal Junction Adenocarcinoma

Gastric Adenocarcinoma

Treatments

Drug: Paclitaxel

Other: Questionnaire Administration

Drug: Hyperthermic Intraperitoneal Chemotherapy

Procedure: Gastrectomy

Procedure: Magnetic Resonance Imaging

Drug: Cisplatin

Procedure: Computed Tomography

Procedure: Positron Emission Tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT05753306

NCI-2023-00431 (Registry Identifier)

22-004680 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Treatment (gastrectomy, HIPEC)

Experimental group

Description:

Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.

Treatment: