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Completed

NCT Number: NCT00021125

Radiation Therapy in Treating Patients With Head and Neck Cancer

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-melanomatous Skin Cancer Salivary Gland Diseases Salivary Gland Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adjuvant therapy

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Time to local recurrence

Secondary outcomes

  1. Length of survival

  2. Morbidity and toxicity

  3. Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer

Sponsors and collaborators

Lead sponsor

Medical Research Council

Other Gov

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2007
First posted
Jan 27, 2003
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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