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

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. Identifier: NCT00006360
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 4, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation Toxicity Drug: radioprotection Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer
Study Start Date : February 2001
Actual Primary Completion Date : November 2005
Actual Study Completion Date : December 2016

Primary Outcome Measures :
  1. Acute salivary gland toxicity
  2. Locoregional control
  3. Whole mouth saliva output relative to pre-radiotherapy measurements
  4. Acute mucositis and other acute and late toxicities

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


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

Endocrine therapy:

  • Not specified


  • No prior head or neck radiotherapy


  • See Disease Characteristics


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006360

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

Publications of Results:
Other Publications:
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Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00006360     History of Changes
Other Study ID Numbers: RTOG-0022
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016

Keywords provided by Radiation Therapy Oncology Group:
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
radiation toxicity

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Oropharyngeal Neoplasms
Radiation Injuries
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries