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

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00006360
Collaborator
National Cancer Institute (NCI) (NIH)
18
Locations
190
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer
Study Start Date :
Feb 1, 2001
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Dec 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Acute salivary gland toxicity []

  2. Locoregional control []

  3. Whole mouth saliva output relative to pre-radiotherapy measurements []

  4. Acute mucositis and other acute and late toxicities []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Foundation for Cancer Research and Education Phoenix Arizona United States 85013
2 UCSF Comprehensive Cancer Center San Francisco California United States 94115
3 University of Florida Shands Cancer Center Gainesville Florida United States 32610-0385
4 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0010
5 CCOP - Kansas City Kansas City Missouri United States 64131
6 Monmouth Medical Center Long Branch New Jersey United States 07740-6395
7 Community Regional Cancer Center at Community Medical Center Toms River New Jersey United States 08755
8 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
9 M.D. Anderson Cancer Center at University of Texas Houston Texas United States 77030-4009
10 Dixie Regional Medical Center Saint George Utah United States 84770
11 LDS Hospital Salt Lake City Utah United States 84143
12 Community Cancer Center at Rutland Regional Medical Center Rutland Vermont United States 05701
13 CCOP - Marshfield Clinic Research Foundation Marshfield Wisconsin United States 54449
14 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226
15 All Saints Cancer Center at All Saints Healthcare Racine Wisconsin United States 53405
16 Stollery Children's Hospital at University of Alberta Hospital Edmonton Alberta Canada T6G 2R7
17 Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2L 4MI
18 McGill Cancer Centre at McGill University Montreal Quebec Canada H2W 1S6

Sponsors and Collaborators

  • Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Avraham Eisbruch, MD, University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00006360
Other Study ID Numbers:
  • RTOG-0022
  • CDR0000068231
  • RTOG-H-0022
First Posted:
Jan 27, 2003
Last Update Posted:
Oct 22, 2020
Last Verified:
Dec 1, 2016
Keywords provided by Radiation Therapy Oncology Group
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
radiation toxicity
Additional relevant MeSH terms:
Oropharyngeal Neoplasms

Study Results

No Results Posted as of Oct 22, 2020