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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 20, 2008

Last Updated Date

March 4, 2009

Start Date ^†

October 2007

Current Primary Outcome Measures ^†

Percentage of patients with nonprogressive disease at 12 months according to RECIST criteria [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00738868 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized

Condition ^†

Head and Neck Cancer

Intervention ^†

Biological: cetuximab
Radiation: stereotactic body radiation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00738868

Responsible Party

Secondary IDs ^††

COL-CKNO-RERT, COL-0705, INCA-RECF0629

Study Sponsor ^†

Centre Oscar Lambret

Collaborators ^††

Investigators ^†

Study Chair:

Eric Lartigau, MD, PhD

Centre Oscar Lambret

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.