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

NCT00006360 | Completed Phase 1 DMC

• 3 other identifiers: RTOG-0022CDR0000068231RTOG-H-0022
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 18

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Acute salivary gland toxicity

• Locoregional control

• Whole mouth saliva output relative to pre-radiotherapy measurements

• Acute mucositis and other acute and late toxicities

Interventions

radioprotection DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (18)

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0385, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0010, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Community Regional Cancer Center at Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Community Cancer Center at Rutland Regional Medical Center

Rutland, Vermont, 05701, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

All Saints Cancer Center at All Saints Healthcare

Racine, Wisconsin, 53405, United States

Location

Stollery Children's Hospital at University of Alberta Hospital

Edmonton, Alberta, T6G 2R7, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L 4MI, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Related Publications (4)

• 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. doi: 10.3390/curroncol13020005.

  PMID: 17576443 BACKGROUND

• 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.

  PMID: 19540060 RESULT

• 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.

  RESULT

• Garden AS, Harris J, Eisbruch A, Chao KSC, Morrison WH, Harari PM, Swanson TA, Jones CU, Yom SS, Spencer SA, Scrimger R, Shenouda G, Shukla M, Lau HY, Mierzwa M, Torres-Saavedra P, Le QT. Final Report of NRG Oncology RTOG 0022: A Phase 1/2 Study of Conformal and Intensity Modulated Radiation for Oropharyngeal Cancer. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):333-340. doi: 10.1016/j.ijrobp.2023.02.057. Epub 2023 Mar 15. No abstract available.

  PMID: 36925074 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Radiation Injuries; Squamous Cell Carcinoma of Head and Neck

Interventions

Radiation Protection; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiologic Health; Public Health; Environment and Public Health; Therapeutics

Study Officials

• Avraham Eisbruch, MD

  University of Michigan Rogel Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2000
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Primary Completion: November 1, 2005
• Study Completion: December 1, 2016
• Last Updated: October 22, 2020

Record last verified: 2016-12

Locations

CA (3); US (15)