Radiation Therapy in Treating Patients With Head and Neck Cancer

This study has been completed.

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00021125

First received: July 11, 2001

Last updated: February 6, 2009

Last verified: December 2002

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

February 6, 2009

Start Date ^ICMJE

July 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00021125 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy in Treating Patients With Head and Neck Cancer

Official Title ^ICMJE

A Randomized Controlled Trial Of CHARTWEL (a Continuous Hyperfractionated Accelerated Radiotherapy Schedule) Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Cancer
Non-Melanomatous Skin Cancer

Intervention ^ICMJE

Procedure: adjuvant therapy
Radiation: radiation therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

460

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00021125

Other Study ID Numbers ^ICMJE

CDR0000068750, MRC-CH03, EU-20121, ISRCTN62576956

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Medical Research Council

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

M. I. Saunders, MD

Mount Vernon Cancer Centre at Mount Vernon Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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