A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 250
- Locations
- 237
- Primary Endpoint
- Local Control
Study Overview
Brief 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.
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •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
- •No prior complete stripping or laser excision of all gross disease
Exclusion Criteria
- Not provided
Arms & Interventions
Radiation therapy - conventional fractionation
Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
Intervention: radiation therapy (Radiation)
Radiation therapy - hyperfractionation
Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions
Intervention: radiation therapy (Radiation)
Outcomes
Primary Outcomes
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
- Acute Toxicity(From start of treatment to 90 days)
- Disease-free Survival(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.)
- Overall Survival(From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years)
- Late Toxicity(From 91 days after start of treatment to last follow-up.)