Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients … (NCT00025090) | Clinical Trial Compass
CompletedPhase 3
Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer
United Kingdom600 participantsStarted 2001-03
Plain-language summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known if fluorouracil plus radiation therapy is more effective with or without additional chemotherapy in treating anal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus radiation therapy with or without additional chemotherapy in treating patients who have primary anal cancer.
Who can participate
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 primary epidermoid anal cancer
* Squamous cell
* Basaloid
* Cloacogenic
* No adenocarcinoma, malignant melanoma, mucoepidermoid carcinoma, lymphoma, or microinvasive anal intraepithelial neoplasia (without evidence of invasive disease) in the anal canal or margin
* No metastatic disease
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
Hepatic:
* Liver function tests no greater than 2 times normal
Renal:
* Glomerular filtration rate at least 50 mL/min
Cardiovascular:
* No cardiovascular disease
* No uncontrolled angina pectoris
* No heart failure
* No clinically significant cardiac arrhythmias
Other:
* HIV negative
* No other significant concurrent illness
* Not predominately bed-bound or frail
* No severe sepsis
* No other prior or concurrent cancer or illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to pelvis
Surgery:
* Not specified
Other:
* No prior therapy for anal cancer
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
1
Complete response rate at 6 months
2
Acute toxicity as measured up to 4 weeks after chemoradiation
3
Recurrence-free survival
Trial details
NCT IDNCT00025090
SponsorUniversity College London (UCL) Cancer Institute