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


Phase 3
N/A
N/A
Not Enrolling
Both
Head and Neck Cancer, Non-melanomatous Skin Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Time to local recurrence

Safety Issue:

No

Principal Investigator

M. I. Saunders, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mount Vernon Cancer Centre at Mount Vernon Hospital

Authority:

United States: Federal Government

Study ID:

MRC-CH03

NCT ID:

NCT00021125

Start Date:

July 2000

Completion Date:

June 2007

Related Keywords:

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

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