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

Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: radiation therapy; Drug: cisplatin; Biological: cetuximab

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nice, France, 06189
    • Centre Antoine Lacassagne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cetuximab	Radiation: radiation therapy; Drug: cisplatin; Biological: cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival at 2 years	2 YEARS

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne
• Investigators: Principal Investigator: Philippe Follana, Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 2, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimated): April 3, 2009

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: stage III squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the oropharynx; tongue cancer
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Tongue Diseases; Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Tongue Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Cetuximab; Cisplatin; Radiotherapy
• Other Study ID Numbers: 2007/23; MERCK-CALACASS-AACER (Other Grant/Funding Number: MERCK); INCA-RECF0623 (Registry Identifier: INCA); 2007-004384-22 (EudraCT Number)