Completed

A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD

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What is being tested

radiation therapy

+ radiation therapy

Radiation
Who is being recruted

Carcinoma+5

+ Carcinoma, Squamous Cell

+ Neoplasms

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 1996
See protocol details

Summary

Principal SponsorRadiation Therapy Oncology Group
Last updated: January 4, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00002727
Principal SponsorRadiation Therapy Oncology Group
Last updated: January 4, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaCarcinoma, Squamous CellNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialSquamous Cell Carcinoma of Head and NeckHead and Neck Neoplasms

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions

Group II

Experimental
Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 237 locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

Comprehensive Cancer Institute of Huntsville

Huntsville, United States

Huntsville Hospital System

Huntsville, United States

MBCCOP - Gulf Coast

Mobile, United States
Completed237 Study Centers