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

Head and Neck Cancer Clinical Trial

Official title:

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006360
• Other study ID #: RTOG-0022
• Secondary ID: CDR0000068231RTO
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2001
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Oropharyngeal Neoplasms
• Radiation Toxicity

Intervention

Drug:
• radioprotection

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital at University of Alberta Hospital	Edmonton	Alberta
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	McGill Cancer Centre at McGill University	Montreal	Quebec
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	All Saints Cancer Center at All Saints Healthcare	Racine	Wisconsin
United States	Community Cancer Center at Rutland Regional Medical Center	Rutland	Vermont
United States	Dixie Regional Medical Center	Saint George	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Community Regional Cancer Center at Community Medical Center	Toms River	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

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.

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). In — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute salivary gland toxicity
Primary	Locoregional control
Primary	Whole mouth saliva output relative to pre-radiotherapy measurements
Primary	Acute mucositis and other acute and late toxicities