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: June 25, 2013
Last verified: December 2002
  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
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


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
Study Completion Date: June 2007
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
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00021125     History of Changes
Other Study ID Numbers: MRC-CH03, CDR0000068750, EU-20121, ISRCTN62576956
Study First Received: July 11, 2001
Last Updated: June 25, 2013
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

Additional relevant MeSH terms:
Skin Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014