Robotic Surgery and Heated Chemotherapy for Treating Stomach Cancer with Limited Spread to the Abdominal Lining, ROBO-CHIP Study

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05753306

Provider View

This study is exploring a new treatment method using robotic surgery and heated chemotherapy to treat stomach cancer that has spread to the lining of the abdomen. The goal is to see if this approach can improve recovery and reduce complications compared to traditional surgery.

Patient Parameters

Program Overview

This phase II study is testing how well a combination of robotic surgery and heated chemotherapy works for patients with stomach cancer that has spread to the lining of the abdomen (peritoneum). Stomach cancer is a major cause of cancer deaths worldwide, and about 30% of patients have peritoneal spread at diagnosis, which leads to poor survival rates. Traditional surgery involves large incisions and can lead to more complications and longer hospital stays. Robotic surgery uses smaller incisions, reducing the risk of complications. Heated chemotherapy (HIPEC) involves delivering warm chemotherapy directly into the abdomen during surgery. This combination may help patients recover better and have fewer complications after surgery.

Description

Primary Objective:

  • To evaluate the short-term side effects and survival without disease for patients with stomach cancer that has spread to the abdominal lining, who undergo robotic surgery and heated chemotherapy.

Secondary Objectives:

  • To collect samples for further research, including:
    • Stool samples for studying gut bacteria before and after surgery.
    • Blood and tissue samples for future studies.
    • Patient feedback on their health using surveys at 1, 3, 6, and 12 months.

Study Outline:

  • Patients will provide stool and blood samples before and after surgery.
  • Patients will undergo robotic surgery to remove the stomach and receive heated chemotherapy with docetaxel and cisplatin.
  • Patients will have CT, MRI, or PET/CT scans throughout the study to monitor progress.

Eligibility Criteria

Inclusion Criteria

  • Age between 18 and 80 years.
  • Good overall health with a performance status of 0 to 2.
  • Confirmed diagnosis of stomach cancer, including certain types of gastroesophageal junction cancer.
  • Adequate blood cell counts and kidney function.
  • Good nutritional status.
  • Cancer spread limited to the abdominal lining, confirmed by tests or imaging.
  • Positive response to previous chemotherapy, shown by a reduction in tumor size or markers.
  • Low Peritoneal Carcinomatosis Index (PCI) score of 7 or less, with a high chance of complete tumor removal.
  • Body Mass Index (BMI) of 35 or less.
  • Must be enrolled in a related study (IRB 14-009873).

Exclusion Criteria

  • Cancer spread beyond the abdominal lining, such as to the liver, lungs, or bones.
  • Presence of malignant fluid buildup in the abdomen at the time of study enrollment.
  • Other health conditions that prevent participation in the study.
  • Inability to comply with study procedures or follow-up.
  • Known severe allergic reactions to the chemotherapy drugs used in the study.

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