CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Cisplatin +2 moredrug
Likely dose
Cisplatin and mitomycin given intraperitoneally during HIPEC; specific doses not stated in published trial informationAI-extracted
Key inclusion· 4
  • Histologic or cytologic proof of adenocarcinoma of stomach or gastroesophageal junction
  • Peritoneal disease: either positive peritoneal cytology or carcinomatosis on laparoscopy/laparotomy
  • Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC
  • ECOG performance status 0-2
Key exclusion· 4
  • Non-peritoneal distant metastases (liver, CNS, lung)
  • Active infections (e.g., pneumonia or wound infection) that would preclude protocol therapy
  • Unstable angina or NYHA grade II or greater congestive heart failure
  • Known life-threatening or severe hypersensitivity to protocol systemic chemotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02891447
NCT02891447Phase 2Completed

A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

M.D. Anderson Cancer Center·interventional·Posted Sep 7, 2016·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Hyperthermic Intraperitoneal Chemotherapy, and 1 other intervention for Gastric Adenocarcinoma and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 7, 2016
Enrollment StartSep 1, 2016
Primary CompletionApr 11, 2023
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 9.8 years ago

Interventions

Cisplatindrug

Given intraperitoneally

Hyperthermic Intraperitoneal Chemotherapydrug

Undergo HIPEC

Mitomycindrug

Given intraperitoneally