TerminatedPhase 2

Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

Stopped: Inadequate toxicity

France16 participantsStarted 2009-03

Plain-language summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.

Who can participate

Age range

18 Years – 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 anal cancer * Squamous cell disease * Locally advanced, non-metastatic disease * One of the following clinical TNM stages: * T2, N0, M0 (largest diameter ≥ 3 cm) * T3-T4, N0, M0 * Any T, N1-N3, M0 * No undifferentiated small cell carcinoma or adenocarcinoma * Measurable disease according to RECIST criteria * Undergone endorectal ultrasound or MRI to evaluate the primary tumor * Undergone thoraco-abdomino-pelvic scan to evaluate tumor extension * Disease suitable to receive radiotherapy and chemotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Leukocytes ≥ 4,000/mm\^3 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Creatinine clearance \> 60 mL/min * ALT and AST ≤ 5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Total bilirubin ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * No history of cancer within the past 8 years except for in situ cervical cancer or previously treated basal cell carcinoma of the skin * No contraindications to any component of study therapy * No serious uncontrolled illness * No symptomatic grade 1 angina pectoris or angina pectoris ≥ grade 2 * No congestive heart failure * No peripheral sensory neuropathy * No uncontrolled diabetes * No HIV positivity * No geographical, social, or psychological situations that preclude medical follow up * Affiliated with a social security system * No p…

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

Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment

Trial details

NCT IDNCT00955240

SponsorUNICANCER

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11-26

View on ClinicalTrials.gov More Anal Cancer trials