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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ISupportive care, TreatmentCompletedOver 18NCI, OtherRTOG-0022
CDR0000068231, RTOG-H-0022, RTOG-DEV-1065, NCT00006360

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Avraham EisbruchStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00006360
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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