Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00006360
NCT00006360CompletedPhase 1

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

Radiation Therapy Oncology Group36 sites in 2 countriesStarted: February 2001Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Locations
36
Primary Endpoint
Acute salivary gland toxicity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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)

Loading locations...

Similar Trials

Completed
Phase 1
Radiation Therapy in Treating Patients With Prostate CancerProstate Cancer
NCT00002480Memorial Sloan Kettering Cancer Center
Completed
Phase 2
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal CancerHead and Neck CancerOral Complications of Radiation TherapyRadiation Toxicity
NCT00057785Radiation Therapy Oncology Group68
Completed
Phase 3
Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate CancerProstate Cancer
NCT00062309Fox Chase Cancer Center307
Completed
Phase 3
Radiation Therapy in Treating Patients With Stage I or Stage II Prostate CancerProstate Cancer
NCT00002703Proton Radiation Oncology Group390
Completed
Phase 1
Intensity-Modulated Radiation Therapy With Incorporated Boost and Capecitabine Before Surgery in Treating Patients With Locally Advanced Rectal CancerColorectal Cancer
NCT00084591Fox Chase Cancer Center