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Clinical Trials/NCT00006360
NCT00006360CompletedPhase 1

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

Radiation Therapy Oncology Group36 sites in 2 countriesStarted: February 2001Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Locations
36
Primary Endpoint
Acute salivary gland toxicity

Study Overview

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.

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Acute salivary gland toxicity

Acute mucositis and other acute and late toxicities

Locoregional control

Whole mouth saliva output relative to pre-radiotherapy measurements

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (36)

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