Radiation Therapy in Treating Patients With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021125
• Other study ID #: MRC-CH03
• Secondary ID: CDR0000068750EU-
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2001
• Last updated: June 25, 2013
• Start date: July 2000
• Est. completion date: June 2007

Study information

• Verified date: December 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Non-melanomatous Skin Cancer

Intervention

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to local recurrence			No
Secondary	Length of survival			No
Secondary	Morbidity and toxicity			Yes
Secondary	Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer			No