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Trial record 20 of 25 for:    United States, Indiana | Community Regional Cancer Care
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Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002727
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: March 2003
History of Changes
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
 Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA OF THE VOCAL CORD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 240
Study Start Date: April 1996
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002727

  Show 237 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Andy M. Trotti, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00002727     History of Changes
Other Study ID Numbers: CDR0000064597, RTOG-9512
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on May 22, 2013