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

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

Drug Information available for:

Salicylsalicylic acid Sodium salicylate

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
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:

Skin Diseases

Squamous cell carcinoma

Salicylsalicylic acid

Sodium Salicylate

Skin Neoplasms

Carcinoma

Epidermoid carcinoma

Head and Neck Neoplasms

Carcinoma, squamous cell

Laryngeal carcinoma

Hypopharyngeal cancer

Carcinoma, Squamous Cell

Salivary Gland Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 19, 2008

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