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

Phase 1

Completed

• Conditions: Head and Neck Cancer; Radiation Toxicity

• Registration Number: NCT00006360
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2000-10-04
• Study Start: 2001-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-11
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute salivary gland toxicity
Acute mucositis and other acute and late toxicities
Locoregional control
Whole mouth saliva output relative to pre-radiotherapy measurements

Trial Locations

Locations (18)

University of Florida Shands Cancer Center; 🇺🇸 Gainesville, Florida, United States

Monmouth Medical Center; 🇺🇸 Long Branch, New Jersey, United States

Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada

Community Regional Cancer Center at Community Medical Center; 🇺🇸 Toms River, New Jersey, United States

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States

CCOP - Marshfield Clinic Research Foundation; 🇺🇸 Marshfield, Wisconsin, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Community Cancer Center at Rutland Regional Medical Center; 🇺🇸 Rutland, Vermont, United States

Medical College of Wisconsin Cancer Center; 🇺🇸 Milwaukee, Wisconsin, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

CCOP - Kansas City; 🇺🇸 Kansas City, Missouri, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

M.D. Anderson Cancer Center at University of Texas; 🇺🇸 Houston, Texas, United States

Dixie Regional Medical Center; 🇺🇸 Saint George, Utah, United States

McGill Cancer Centre at McGill University; 🇨🇦 Montreal, Quebec, Canada

Stollery Children's Hospital at University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

All Saints Cancer Center at All Saints Healthcare; 🇺🇸 Racine, Wisconsin, United States