Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer (NCT00003344) | Clinical Trial Compass
CompletedPhase 1/2
Radiation Therapy Plus Irinotecan in Treating Patients With Colon Cancer
United States49 participantsStarted 1998-08
Plain-language summary
RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus irinotecan in treating patients with colon cancer that is recurrent or that cannot be removed surgically.
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 confirmed unresectable, incompletely resected with gross residual disease, or locally recurrent large bowel carcinoma confined to a site within the abdomen or pelvis All disease must be encompassable within a single radiotherapy port No evidence of uncontrolled metastatic disease outside of the planned radiotherapy port
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Not specified Cardiovascular: No history of significant myocardial disease No New York Heart Association class III or IV disease No unstable angina No myocardial infarction in the past 4 months Other: No significant infection or other coexistent medical condition that would preclude protocol therapy Maintain an adequate oral nutrition intake (at least 1,200 calories estimated per day) No greater than 6 bowel movements per day prior to treatment No significant nausea or emesis on optimal antiemetic therapy Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior irinotecan Endocrine therapy: Not specified Radiotherapy: No prior abdominal or pelvic radiotherapy Surgery: At least 3 weeks since laparotomy or laparoscopic procedure with or without resection
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.