RECRUITING

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

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Conditions

Gastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaMetastatic Malignant Neoplasm in the Peritoneum

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-04-20
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05753306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Restricted to 18 to 80 years of age
  2. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  3. * Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomas
  4. * Absolute neutrophil count \>= 1,500 / uL
  5. * Platelets \>= 50,000 / Ul
  6. * Serum creatinine \<= 1.5 mg / dL
  7. * Adequate nutritional status (Albumin \>= 3.5)
  8. * Metastasis confined to the peritoneum:
  9. * Positive peritoneal cytology
  10. * Peritoneal metastasis on diagnostic laparoscopy
  11. * Peritoneal metastasis on imaging
  12. * Response to systemic chemotherapy defined as at least one of the following:
  13. * Reduction (\>= 30%) in standardized uptake value (SUV) max \[Response Evaluation Criteria in Solid Tumors (RECIST) criteria\]
  14. * 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
  15. * Reduction ( \>= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology
  16. * Reduction ( \>= 30%) in serum tumor markers CEA or CA 19-9
  17. * Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeon deems high likelihood for a complete cytoreduction
  18. * Body Mass Index (BMI) =\< 35 kg/m\^2
  1. * Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)
  2. * Malignant ascites at time of study enrollment
  3. * Comorbidities that would preclude protocol therapy
  4. * Subjects deemed unable to comply with study and/or follow-up procedures
  5. * 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

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Travis E Grotz, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Travis E Grotz, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-20
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2023-04-20
Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

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