Cetuximab and Stereotactic Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery

NCT ID: NCT00738868

Last Updated: 2011-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31

Brief Summary

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving cetuximab together with stereotactic radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how giving cetuximab together with stereotactic radiation therapy works in treating patients with recurrent squamous cell carcinoma of the head and neck cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

• Evaluate local control at 12 months in patients with recurrent squamous cell carcinoma of the head and neck treated with cetuximab and stereotactic radiotherapy.

Secondary

• Determine the incidence of cutaneous toxicity.
• Assess the care and development of skin reactions.
• Determine the quality of life of patients treated with this drug.
• Determine tumor response at 2 months.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV once weekly for 5 weeks. Patients undergo stereotactic radiotherapy 3 times weekly during weeks 2 and 3.

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

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cetuximab

Intervention Type: BIOLOGICAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck

• Unresectable disease
• Recurrent disease
• No metastatic disease
• Disease in previously irradiated area must be proven by biopsy or imaging

• At least 3 months between prior radiotherapy and diagnosis of recurrent disease
• Surgery or brachytherapy must be possible
• Measurable or evaluable disease by RECIST criteria
• No available curative therapy

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Not pregnant or nursing
• No psychological, familial, social, or geographical reasons that would make monitoring the patient impossible
• No other malignant disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent participation in another clinical study of an experimental drug

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

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Principal Investigators

Eric Lartigau, MD, PhD

Role: STUDY_CHAIR

Centre Oscar Lambret

Locations

Centre Oscar Lambret

Lille, , France

Countries

France

Other Identifiers

COL-CKNO-RERT

Identifier Type: -

Identifier Source: secondary_id

COL-0705

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0629

Identifier Type: -

Identifier Source: secondary_id

CDR0000589673

Identifier Type: -

Identifier Source: org_study_id