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

Primary Purpose

Head and Neck Cancer, Radiation Toxicity

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
radioprotection
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, radiation toxicity

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation for Cancer Research and Education
  • UCSF Comprehensive Cancer Center
  • University of Florida Shands Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • CCOP - Kansas City
  • Monmouth Medical Center
  • Community Regional Cancer Center at Community Medical Center
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • M.D. Anderson Cancer Center at University of Texas
  • Dixie Regional Medical Center
  • LDS Hospital
  • Community Cancer Center at Rutland Regional Medical Center
  • CCOP - Marshfield Clinic Research Foundation
  • Medical College of Wisconsin Cancer Center
  • All Saints Cancer Center at All Saints Healthcare
  • Stollery Children's Hospital at University of Alberta Hospital
  • Centre Hospitalier de l'Universite de Montreal
  • McGill Cancer Centre at McGill University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 4, 2000
Last Updated
October 21, 2020
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006360
Brief Title
Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
Official Title
Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Radiation Toxicity
Keywords
stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, radiation toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
radioprotection
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Acute salivary gland toxicity
Title
Locoregional control
Title
Whole mouth saliva output relative to pre-radiotherapy measurements
Title
Acute mucositis and other acute and late toxicities

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avraham Eisbruch, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0385
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0010
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
Community Regional Cancer Center at Community Medical Center
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Dixie Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Community Cancer Center at Rutland Regional Medical Center
City
Rutland
State/Province
Vermont
ZIP/Postal Code
05701
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
All Saints Cancer Center at All Saints Healthcare
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
Facility Name
Stollery Children's Hospital at University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R7
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4MI
Country
Canada
Facility Name
McGill Cancer Centre at McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17576443
Citation
Ploquin N, Lau H, Dunscombe P. Intensity modulated and three-dimensional conformal radiation therapy plans for oropharyngeal cancer: a comparison of their sensitivity to set-up errors and uncertainties. Curr Oncol. 2006 Apr;13(2):61-6.
Results Reference
background
PubMed Identifier
19540060
Citation
Eisbruch A, Harris J, Garden AS, Chao CK, Straube W, Harari PM, Sanguineti G, Jones CU, Bosch WR, Ang KK. Multi-institutional trial of accelerated hypofractionated intensity-modulated radiation therapy for early-stage oropharyngeal cancer (RTOG 00-22). Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1333-8. doi: 10.1016/j.ijrobp.2009.04.011. Epub 2009 Jun 18.
Results Reference
result
Citation
Eisbruch A, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT for oropharyngeal cancer (RTOG 00-22): early results. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-79, S46-7, 2006.
Results Reference
result

Learn more about this trial

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

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