TerminatedPhase 3

Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer

United States340 participantsStarted 2010-08

Plain-language summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating mitomycin C to several degrees above normal body temperature and infusing it into the area around the tumor may kill more tumor cells. Giving mitomycin C after surgery may kill any remaining tumor cells. It is not yet known whether standard therapy is more effective with or without surgery followed by mitomycin C. PURPOSE: This randomized phase III trial is studying standard therapy with or without surgery and mitomycin C in treating patients with advanced limited peritoneal dissemination of colon cancer

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colon adenocarcinoma meeting the following criteria: * Newly diagnosed disease * Advanced disease * Confirmed synchronous or metachronous limited peritoneal disease dissemination * No appendiceal or rectal cancer * No signet ring cell type * Disease amenable to complete cytoreduction surgery as indicated by: * Peritoneal Cancer Index (PCI) ≤ 20 by helical CT scan and/or staging laparoscopy * No parenchymal hepatic metastases * No clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase), or radiological (by ultrasound, CT scan, or MRI) biliary obstruction * No symptomatic malignant ascites requiring palliative paracentesis * Small volume of disease in the gastro-hepatic ligament defined by a \< 5 cm mass in the epigastric region on cross-sectional imaging * No cross-sectional imaging findings indicative of multi-segmental (\> 1 site) small bowel obstruction, small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening, or loss of mesenteric vascular clarity * No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal, or peri-aortic) metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * ANC \> 1,200/mm³ * WBC \> 4,000/mm³ * Platelet count 150,000/mm³ * INR ≤ 1.5 * Patients on therapeutic anticoagulant f…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival (OS)

Trial details

NCT IDNCT01167725

SponsorAlliance for Clinical Trials in Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

View on ClinicalTrials.gov More Colorectal Cancer trials