CompletedPhase 2

Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer

France53 participantsStarted 2008-03

Plain-language summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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 chemotherapy together with radiation therapy and cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.

Who can participate

Age range

18 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 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * Must have undergone complete macroscopic resection * Presence of ≥ 1 of the following poor prognostic factors after complete resection: * Incomplete microscopic resection and N+ * Complete microscopic resection and \> 2 N+ * Vascular and/or lymphatic embolism * At least 2 peripheral nerve invasions * Positive surgical margins and pT4 lesion * No metastases PATIENT CHARACTERISTICS: * WHO performance status 0-2 * ANC \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL * Bilirubin \< 1.5 times upper limit of normal (ULN) * Serum creatinine \< 1.25 times ULN and/or creatinine clearance \> 55 mL/min * Not pregnant or nursing * Fertile patients must use effective contraception * No serious and disabling cardiac, renal, hepatic, or respiratory failure * No coronary artery disease or myocardial infarction within the past year * No uncontrolled cardiac arrhythmia * Other active and serious diseases allowed at discretion of the investigator * No known severe allergy to cisplatin, cetuximab, or any of their excipients * No other malignant disease diagnosed within the past 5 years except for basal cell carcinoma of the skin or in situ cervical cancer * No psychological, familial, social, or geographic situations that preclude clinical follow up PRIOR CONCURRENT THERAPY: * No prior treatment (except surgery) for this cance…

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

Disease-free survival at 2 years

Timeframe: 2 YEARS

Trial details

NCT IDNCT00875849

SponsorCentre Antoine Lacassagne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-02

View on ClinicalTrials.gov More Head and Neck Cancer trials