CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Mitomycin C +2 moredrug
Likely dose
Mitomycin C 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02092298
NCT02092298Phase 2Completed
CompareCT.gov

A Phase II Study of Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Gastric Carcinomatosis or Positive Cytology

M.D. Anderson Cancer Center·interventional·Posted Mar 20, 2014·Updated Jun 15, 2021

In Brief

A Phase 2 clinical trial evaluating Mitomycin C, Cisplatin, and 1 other intervention for Gastrointestinal Cancer. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or gastroesophageal cancer. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 20, 2014
Enrollment StartMay 8, 2014
Primary CompletionMay 12, 2020
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 12.3 years ago

Interventions

Mitomycin Cdrug

Mitomycin C 30 mg delivered laparoscopically for 60 minutes.

Cisplatindrug

Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.

Sodium Thiosulfatedrug

Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.