Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer

October 21, 2020 updated by: Radiation Therapy Oncology Group

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy.
  • Determine the nature and prevalence of acute and late side effects of this treatment in these patients.
  • Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment.

OUTLINE: This is a multicenter study.

Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27 months.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R7
        • Stollery Children's Hospital at University of Alberta Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill Cancer Centre at McGill University
      • Montreal, Quebec, Canada, H2L 4MI
        • Centre Hospitalier de L'Universite de Montreal
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Foundation for Cancer Research and Education
    • California
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
    • Florida
      • Gainesville, Florida, United States, 32610-0385
        • University of Florida Shands Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0010
        • University of Michigan Comprehensive Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
    • New Jersey
      • Long Branch, New Jersey, United States, 07740-6395
        • Monmouth Medical Center
      • Toms River, New Jersey, United States, 08755
        • Community Regional Cancer Center at Community Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • Texas
      • Houston, Texas, United States, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
    • Utah
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Community Cancer Center at Rutland Regional Medical Center
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center
      • Racine, Wisconsin, United States, 53405
        • All Saints Cancer Center at All Saints Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically proven stage II or III (T1-T2, N0-N1) squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or palate)

    • Lymph nodes in both sides of neck at risk of metastatic disease and require radiotherapy
    • Patients upstaged by imaging to N2 are eligible

  • Measurable or evaluable disease

    • Greater than 1 cm in one dimension or with necrotic regions if by CT or MRI scan
  • Surgery of the primary tumor or lymph nodes limited to incisional or excisional biopsies
  • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No active untreated infection
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or a carcinoma not of head or neck origin
  • No concurrent major medical or psychiatric illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • More than 3 months since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior head or neck radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent treatment for head and neck cancer
  • No prophylactic amifostine or pilocarpine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Acute salivary gland toxicity
Locoregional control
Whole mouth saliva output relative to pre-radiotherapy measurements
Acute mucositis and other acute and late toxicities

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Avraham Eisbruch, MD, University of Michigan Rogel Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-0022
  • CDR0000068231
  • RTOG-H-0022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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