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

NCT ID: NCT00875849

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-12-31

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 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.

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 complete surgical resection.

Secondary

• Evaluate quality of life.
• Evaluate tolerability.
• Evaluate overall survival.
• Analyze germinal polymorphisms.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on day 1. Treatment with cetuximab repeats every week for up to 8 courses. Patients also receive cisplatin IV on day 8. Treatment with cisplatin repeats every 3 weeks for up to 3 courses. Patients undergo concurrent radiotherapy 5 times a week for 7 weeks beginning on day 8.

After completion of study treatment, patients are followed at 1 month and then every 3 months for 2 years.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: BIOLOGICAL

cisplatin

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Interventions

cetuximab

Intervention Type: BIOLOGICAL

cisplatin

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Follana

Role: PRINCIPAL_INVESTIGATOR

Centre Antoine Lacassagne

Locations

Centre Antoine Lacassagne

Nice, , France

Countries

France

Other Identifiers

MERCK-CALACASS-AACER

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

INCA-RECF0623

Identifier Type: REGISTRY

Identifier Source: secondary_id

2007-004384-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2007/23

Identifier Type: -

Identifier Source: org_study_id