Radiation Therapy in Treating Patients With Head and Neck Cancer - Full Text View

Sponsored by:	Medical Research Council
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00021125

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer.

Condition	Intervention	Phase
Head and Neck Cancer Non-Melanomatous Skin Cancer	Procedure: adjuvant therapy Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders Skin Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Randomized Controlled Trial Of CHARTWEL (a Continuous Hyperfractionated Accelerated Radiotherapy Schedule) Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients

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

Primary Outcome Measures:

Time to local recurrence [ Designated as safety issue: No ]

Secondary Outcome Measures:

Length of survival [ Designated as safety issue: No ]
Morbidity and toxicity [ Designated as safety issue: Yes ]
Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer [ Designated as safety issue: No ]

Estimated Enrollment:	460
Study Start Date:	July 2000

Detailed Description:

OBJECTIVES:

Compare adjuvant continuous hyperfractionated accelerated radiotherapy vs conventional radiotherapy, in terms of preventing disease recurrence, in patients with head and neck cancer.
Compare the early and late toxic effects of these treatments in this patient population.
Compare disease-free and overall survival of patients receiving these treatments.
Assess quality of life in patients receiving these treatments.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients undergo radiotherapy 3 times daily, with an interval of at least 6 hours between any 2 treatments, 5 days a week, for just over 2 weeks, for a total of 13-14 treatment days.
Arm II: Patients undergo radiotherapy daily, 5 days a week, for 6-6.5 weeks. Quality of life is assessed at baseline and then annually for 5 years.

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

PROJECTED ACCRUAL: A total of 460 patients (230 per arm) will be accrued for this study within 2-3 years.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed squamous cell carcinoma of the head and neck including, but not limited to, the following:
- Oral cavity
- Oropharynx
- Hypopharynx
- Larynx
- Nasal sinuses
- Skin
Undergone curative surgery within the past 70 days
- All macroscopic disease removed
At high or intermediate risk of recurrence
- No low risk of recurrence
No evidence of distant metastases
Considered treatable by radiotherapy

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other prior or concurrent malignancy that would preclude study participation
No other uncontrolled medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021125

Locations

United Kingdom, England
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN

Sponsors and Collaborators

Medical Research Council

Investigators

Study Chair:

M. I. Saunders, MD

Mount Vernon Cancer Centre at Mount Vernon Hospital

More Information

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

Study ID Numbers:	CDR0000068750, MRC-CH03, EU-20121, ISRCTN62576956
Study First Received:	July 11, 2001
Last Updated:	December 25, 2007
ClinicalTrials.gov Identifier:	NCT00021125
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

squamous cell carcinoma of the skin
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx

stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
salivary gland squamous cell carcinoma
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer

Study placed in the following topic categories:

Epidermoid carcinoma
Skin Diseases
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma

Hypopharyngeal cancer
Skin Neoplasms
Carcinoma, Squamous Cell
Salivary Gland Diseases
Dental Caries
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009