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 range18 Years

SexALL

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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…

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