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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00006360

First received: October 4, 2000

Last updated: March 25, 2010

Last verified: October 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

October 4, 2000

Last Updated Date

March 25, 2010

Start Date ^ICMJE

February 2001

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Acute salivary gland toxicity [ Designated as safety issue: Yes ]
Locoregional control [ Designated as safety issue: No ]
Whole mouth saliva output relative to pre-radiotherapy measurements [ Designated as safety issue: No ]
Acute mucositosis and other acute and late toxicities [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00006360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

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 Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Head and Neck Cancer
Radiation Toxicity

Intervention ^ICMJE

Drug: radioprotection
Radiation: radiation therapy

Study Arm (s)

Not Provided

Publications *

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. 2009 Jun 17; [Epub ahead of print]
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.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00006360

Other Study ID Numbers ^ICMJE

CDR0000068231, RTOG-0022, RTOG-H-0022, RTOG-DEV-1065

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Radiation Therapy Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Avraham Eisbruch, MD

University of Michigan Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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