ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002727
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 4, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

November 1, 1999
January 27, 2003
January 4, 2017
April 1996
October 2005   (Final data collection date for primary outcome measure)
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. ]
Not Provided
Complete list of historical versions of study NCT00002727 on ClinicalTrials.gov Archive Site
  • 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. ]
Not Provided
Not Provided
Not Provided
 
Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord
A RANDOMIZED STUDY OF HYPERFRACTIONATION VERSUS CONVENTIONAL FRACTIONATION IN T2 SQUAMOUS CELL CARCINOMA 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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Head and Neck Cancer
Radiation: radiation therapy
  • Active Comparator: Radiation therapy - conventional fractionation
    Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions
    Intervention: Radiation: radiation therapy
  • Experimental: Radiation therapy - hyperfractionation
    Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions
    Intervention: Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Not Provided
December 2016
October 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00002727
RTOG-9512
CDR0000064597
Yes
Not Provided
Not Provided
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Andy M. Trotti, MD H. Lee Moffitt Cancer Center and Research Institute
Radiation Therapy Oncology Group
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP