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

Gastric Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753306
• Other study ID #: 22-004680
• Secondary ID: NCI-2023-0043122
• Status: Recruiting
• Phase: Phase 2
• Start date: March 16, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE: I. To assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy. SECONDARY OBJECTIVES: I. To obtain a biorepository for additional translational research including: Ia. Stool samples for shotgun metagenomic sequencing and metabolomic quantification of the fecal microbiome before and after gastrectomy; Ib. Blood and peritoneal tissue biobanked for future investigations; Ic. Patient reported outcomes using the Mayo Clinic Upper Digestive Disease Survey questionnaires at 1, 3, 6 and 12 months. OUTLINE: 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 computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT scans throughout the trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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
• Must enroll in Institutional Review Board (IRB) 14-009873 (NCT02530983)

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Metastatic Malignant Neoplasm in the Peritoneum
• Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo stool and blood sample collection

Drug:
• Cisplatin
Given via HIPEC

Procedure:
• Computed Tomography
Undergo CT scan or PET/CT

Drug:
• Docetaxel
Given via HIPEC

Procedure:
• Gastrectomy
Undergo robotic gastrectomy

Drug:
• Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC

Procedure:
• Magnetic Resonance Imaging
Undergo MRI
• Positron Emission Tomography
Undergo PE/CT

Other:
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 1 year
Primary	30 day readmission rate	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 30 days post surgery
Primary	30 day Clavien-Dindo grade III complications	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 30 days post surgery
Secondary	Disease-free survival	Descriptive statistics such as mean, standard deviation, median and range summarized. Time estimated using the Kaplan-Meier method. Two-sided log-rank test used to assess differences of time to events between groups.	Up to 5 years
Secondary	Peritoneal recurrence free survival	Descriptive statistics such as mean, standard deviation, median and range summarized. Time estimated using the Kaplan-Meier method. Two-sided log-rank test used to assess differences of time to events between groups.	Up to 5 years
Secondary	Overall survival	Descriptive statistics such as mean, standard deviation, median and range summarized. Time estimated using the Kaplan-Meier method. Two-sided log-rank test used to assess differences of time to events between groups.	Up to 5 years
Secondary	Open conversion rate	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 42 months
Secondary	Opioid consumption in morphine milligram equivalents	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 42 months
Secondary	Nursing reported pain scores	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 42 months
Secondary	Estimated blood loss	Descriptive statistics such as mean, standard deviation, median and range summarized.	Up to 42 months
Secondary	Operative time	Descriptive statistics such as mean, standard deviation, median and range summarized.	Intraoperative

External Links

•   Mayo Clinic Clinical Trials