Completed

NCT Number: NCT00738868

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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Salivary Gland Diseases Salivary Gland Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetuximab

Biological

Stereotactic Body Radiation Therapy

Radiation

Primary outcomes

Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Re-irradiation and Stereotactic Cetuximab in Patients With Recurrent Carcinoma of the Head and Neck

Important dates

Study start: 2007
Primary completion: 2011
First posted: Aug 21, 2008
Registry last updated: May 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed