Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD|
- 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. ]
- 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. ]
|Study Start Date:||April 1996|
|Study Completion Date:||December 2016|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
Active Comparator: Radiation therapy - conventional fractionation
Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
|Radiation: radiation therapy|
Experimental: Radiation therapy - hyperfractionation
Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions
|Radiation: radiation therapy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002727
Show 237 Study Locations
|Study Chair:||Andy M. Trotti, MD||H. Lee Moffitt Cancer Center and Research Institute|