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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer

Treatments: Radiation: radiation therapy

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00002727

CDR0000064597

RTOG-9512

Details and patient eligibility

About

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 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Radiation therapy - conventional fractionation

Active Comparator group

Description:

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

Treatment:

Radiation: radiation therapy

Radiation therapy - hyperfractionation

Experimental group

Description:

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

Treatment:

Radiation: radiation therapy