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Radiation Therapy in Treating Patients With Head and Neck Cancer

Primary Purpose

Head and Neck Cancer, Non-melanomatous Skin Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
adjuvant therapy
radiation therapy
Sponsored by
Medical Research Council
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

Outcomes

Primary Outcome Measures

Time to local recurrence

Secondary Outcome Measures

Length of survival
Morbidity and toxicity
Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer

Full Information

First Posted
July 11, 2001
Last Updated
June 25, 2013
Sponsor
Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT00021125
Brief Title
Radiation Therapy in Treating Patients With Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2002
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Council

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Non-melanomatous Skin Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Time to local recurrence
Secondary Outcome Measure Information:
Title
Length of survival
Title
Morbidity and toxicity
Title
Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. I. Saunders, MD
Organizational Affiliation
Mount Vernon Cancer Centre at Mount Vernon Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

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Radiation Therapy in Treating Patients With Head and Neck Cancer

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