NCT00002727

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00002727

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Head and Neck Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: Radiation therapy - conventional fractionation, Radiation therapy - hyperfractionation

Sponsor

Radiation Therapy Oncology Group