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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.
 
ClinicalTrials.gov Identifier: NCT00006360
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

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:

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.

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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

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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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00006360


Locations
Show Show 18 study locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
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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
ClinicalTrials.gov Identifier: NCT00006360    
Other Study ID Numbers: RTOG-0022
CDR0000068231
RTOG-H-0022
RTOG-DEV-1065
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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Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases