Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be … (NCT00002523) | Clinical Trial Compass
CompletedPhase 3
Radiation Therapy, Surgery, and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Belgium, France, Germany1,011 participantsStarted 1993-04
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.
Who can participate
Age range
80 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 resectable adenocarcinoma of the rectum
* Any grade
* Tumor macroscopically within 15 cm of anal margin on rigid rectoscopy
* Tumor tethered or partially fixed on digital rectal exam and/or T3-4 on rectal ultrasound
* No acute or subacute bowel obstruction without colostomy diversion
* No chronic inflammatory disease of the ileum and/or colon
* No primary adenocarcinoma of the anal canal
* No distant metastasis
PATIENT CHARACTERISTICS:
Age:
* 80 and under
Performance status:
* WHO 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count greater than 2,000/mm\^3
* Platelet count greater than 130,000/mm\^3
Hepatic:
* Not specified
Renal:
* Creatinine less than 1.36 mg/dL
Cardiovascular:
* No angina pectoris
Other:
* No other prior malignancy except basal cell skin cancer or carcinoma in situ of the uterine cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy for adenocarcinoma of the rectum
Chemotherapy
* No prior chemotherapy for adenocarcinoma of the rectum
Endocrine therapy
* No prior endocrine therapy for adenocarcinoma of the rectum
Radiotherapy
* No prior radiotherapy for adenocarcinoma of the rectum
Surgery
* No prior surgery for adenocarcinoma of the rectum
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.
Trial details
NCT IDNCT00002523
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC