Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatment radiation therapy
Phase phase 3
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date April 1996
End date October 2005
Trial size 250 participants
Trial identifier NCT00002727, CDR0000064597, RTOG-9512

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
radiation therapy
(Experimental)
Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions
radiation therapy

Primary Outcomes

Measure
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 Outcomes

Measure
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.