Status:
COMPLETED
Chemotherapy, Radiation Therapy, and Cetuximab in Treating Patients With the Head and Neck Cancer
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 use...
Detailed Description
OBJECTIVES: Primary * Evaluate disease-free survival at 2 years in patients with poor prognosis squamous cell carcinoma of the head and neck treated with chemoradiotherapy and cetuximab after comple...
Eligibility Criteria
Inclusion
- 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 cancer or another head and neck cancer
- At least 3 months since prior treatment with an investigational agent
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00875849
Start Date
March 1 2008
End Date
December 1 2013
Last Update
September 30 2025
Active Locations (1)
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1
Centre Antoine Lacassagne
Nice, France, 06189