Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00047008

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: cisplatin Procedure: conventional surgery Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Phase III Trial of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2002

Detailed Description:

OBJECTIVES:

Primary

Compare overall survival of patients with stage III or IV squamous cell carcinoma of the head and neck treated with conventional vs accelerated radiotherapy and concurrent cisplatin with or without surgical resection.

Secondary

Compare local-regional control of disease and disease-free rates in patients treated with these regimens.
Compare the acute and late toxicity of these regimens in these patients.
Compare quality of life, perception of side effects, and performance status of patients treated with these regimens.
Determine whether epidermal growth factor receptor and cyclo-oxygenase-2 expressions are independent prognostic markers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor site (larynx vs other), nodal stage (N0 vs N1 or N2a or N2b vs N2c or N3), and Zubrod performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo standard fractionation radiotherapy 5 days a week for 7 weeks. Patients also receive cisplatin IV on days 1, 22, and 43.
Arm II: Patients undergo accelerated fractionation radiotherapy 5 days a week for 3.5 weeks and then twice a day, 5 days a week, for 2.5 weeks. Patients also receive cisplatin IV on days 1 and 22.

Patients with biopsy-proven relapsed disease more than 3 months after completion of therapy undergo surgical resection of the primary tumor.

Quality of life is assessed at baseline, during one of the last 2 weeks of treatment, at 3 and 12 months, and then annually for 4 years.

Patients are followed at 6-8 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 720 patients (360 per treatment arm) will be accrued for this study within 3 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)
No metastases below the clavicle or more distant by clinical exam or radiology

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count at least 2,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 mg/dL
ALT or AST no greater than 2 times upper limit of normal

Renal

Creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 50 mL/min
Calcium normal

Cardiovascular

No symptomatic coronary artery disease (angina)
No myocardial infarction within the past 6 months

Other

No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
No simultaneous primary tumors
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to the head and neck except radioactive iodine therapy

Surgery

No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease
- No radical or modified neck dissection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047008

Show 195 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

K. Kian Ang, MD, PhD

M.D. Anderson Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Ang K, Pajak T, Rosenthal DI, et al.: A phase III trial to compare standard versus accelerated fractionation in combination with concurrent cisplatin for head and neck carcinomas (RTOG 0129): report of compliance and toxicity. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-21, S12-13, 2007.

Study ID Numbers:	CDR0000257233, RTOG-0129, RTOG-H-0129, RTOG-DEV-1069
Study First Received:	October 3, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00047008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx

stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx

Study placed in the following topic categories:

Epidermoid carcinoma
Cisplatin
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell

Laryngeal carcinoma
Hypopharyngeal cancer
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009