CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 enrolled
Drug / intervention
mitomycin C +4 moredrug
Likely dose
Not stated in 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/NCT01580410
NCT01580410Phase 2Completed

A Multi-Center, Open-Label, Randomized Phase II Trial to Evaluate Hematologic Toxicities After HIPEC With Oxaliplatin or Mitomycin C in Patients With Appendiceal Tumors

Wake Forest University Health Sciences·interventional·Posted Apr 19, 2012·Updated Jul 3, 2018

In Brief

A Phase 2 clinical trial evaluating mitomycin C, oxaliplatin, and 3 other interventions for Carcinoma of the Appendix and Primary Peritoneal Cavity Cancer. Completed, enrolled 136 participants across 3 sites.

Detailed Summary

This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2012
Enrollment StartMay 1, 2009
Primary CompletionOct 1, 2015
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 14.2 years ago

Interventions

mitomycin Cdrug

Given by HIPEC

oxaliplatindrug

Given by HIPEC

therapeutic conventional surgeryprocedure

Undergo surgery

quality-of-life assessmentother

Ancillary studies

hyperthermic intraperitoneal chemotherapydrug

Undergo HIPEC