Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord

Overview

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord. PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord.

Full Title of Study: “A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2005

Detailed Description

OBJECTIVES: – Compare the local response rate in patients with stage II invasive squamous cell carcinoma of the true vocal cord treated with hyperfractionation vs conventional fractionation radiotherapy. – Compare the acute and late toxic effects of these regimens in this patient population. – Compare the overall and disease-free survival patterns in this patient population treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to substage (T2a vs T2b). Patients are randomized to 1 of 2 treatment arms. – Arm I: Patients undergo conventional radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 2 weeks. – Arm II: Patients undergo hyperfractionation radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1.6 weeks. Patients with biopsy-proven persistent disease at least 6 weeks after completion of radiotherapy undergo salvage surgery with neck dissection (at the discretion of the surgeon). Patients are followed at 4 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study within 3.2 years.

Interventions

  • Radiation: radiation therapy

Arms, Groups and Cohorts

  • Active Comparator: Radiation therapy – conventional fractionation
    • Radiation therapy – conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
  • Experimental: Radiation therapy – hyperfractionation
    • Radiation therapy – hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions

Clinical Trial Outcome Measures

Primary Measures

  • Local Control
    • Time Frame: From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.

Secondary Measures

  • Acute Toxicity
    • Time Frame: From start of treatment to 90 days
  • Late Toxicity
    • Time Frame: From 91 days after start of treatment to last follow-up.
  • Overall Survival
    • Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years
  • Disease-free Survival
    • Time Frame: From randomization to date of failure (local, regional, or distant progression, second primary tumor, or death) or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Histologically proven invasive squamous cell carcinoma of the true vocal cord – Stage II (T2a/b N0) disease with bulk of tumor present on vocal cord (i.e., the epicenter) with extension to adjacent areas – No verrucal carcinoma or adenocarcinoma – No extension to pre-epiglottic space or pyriform sinus – No fixed cord or cartilage invasion – No evidence of adenopathy, including any of the following: – Nodes larger than 1 cm by radiography – Nodes containing a low central density consistent with necrosis by radiography – Clinically palpable nodes larger than 1 cm and firm in consistency – No recurrent or persistent disease – No evidence or suspicion of distant metastases PATIENT CHARACTERISTICS: Age: – 18 and over Performance status: – Karnofsky 60-100% Life expectancy: – Not specified Hematopoietic: – Not specified Hepatic: – Not specified Renal: – Not specified Other: – No other malignancy within the past 5 years except nonmelanomatous skin cancer – Not pregnant or nursing – Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: – Not specified Chemotherapy: – No prior chemotherapy Endocrine therapy: – Not specified Radiotherapy: – No prior radiotherapy to the mid-neck or larynx Surgery: – No prior complete stripping or laser excision of all gross disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radiation Therapy Oncology Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andy M. Trotti, MD, Study Chair, H. Lee Moffitt Cancer Center and Research Institute

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