Phase III of Unilateral Neck Irradiation With Amifostine in Patients With SCC of the Head and Neck - Full Text View

Sponsor:	Beth Israel Medical Center
Information provided by:	Beth Israel Medical Center
ClinicalTrials.gov Identifier:	NCT00206752

Purpose

The purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly only one side squamous cell cancer of the head and neck and to assess the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy with the simultaneous administration of amifostine.

Condition	Intervention	Phase
Squamous Cell Carcinoma of the Head and Neck	Radiation: amifostine plus radiation therapy (amifostine arm) Radiation: definitive external beam radiation in the ipsilateral neck	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation Combined With Amifostine in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy.

Resource links provided by NLM:

Drug Information available for: Amifostine

U.S. FDA Resources

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:

FACT (head and neck);Xerostomia related Quality of Life Questionnaire [ Time Frame: September 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment:	66
Study Start Date:	August 2004
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental definitive external beam radiation in the ipsilateral neck plus Ethyol	Radiation: amifostine plus radiation therapy (amifostine arm) definitive external beam radiation in the ipsilateral neck + Amifostine is given at 500 mg subcutaneously within 60 minutes prior to each dose of EBRT. Radiation: definitive external beam radiation in the ipsilateral neck definitive external beam radiation in the ipsilateral neck
2: Experimental Unilateral radiation therapy	Radiation: definitive external beam radiation in the ipsilateral neck definitive external beam radiation in the ipsilateral neck

Detailed Description:

Patients will be treated with definitive external beam radiation plus/minus chemotherapy plus/minus neck dissection in the ipsilateral neck (post radiation). The primary site will be treated with definitive radiation therapy, or definitive surgery plus post-operative radiation therapy. Primary endpoints are loco-regional control, as well as quality of life, xerostomia, mucositis, and neck fibrosis.

Amifostine will be administered within 60 minutes prior to each daily fraction of radiation. It will be administered as two subcutaneous injections (1.7 mL each). Salivary evaluations shall be performed prior to the initiation of radiation therapy, during the second week of EBRT, and at the completion of radiation. Evaluations will also be conducted at 3, 6, and 12 months after the completion of EBRT.

Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT. Evaluations will also be conducted at 3 and 6 months after the completion of EBRT. Two standardized mucositis scales will be used: the RTOG scale and the WHO scale.

Clinical response will be evaluated by physical exam and PET/CT. PET/CT scans will be done at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Squamous cell carcinoma of the oral cavity or oropharynx, with the primary lesion >1 cm from the midline.
Patient has no clinical or radiologic evidence of contralateral neck node metastases.
No evidence of distant metastasis.
No previous history of radiation therapy or chemotherapy
performance status 0-2
Age >= 18
Signed informed consent
Patients must be accessible for treatment and follow-up

Exclusion Criteria:

HIV positive patients
Pregnancy or any patients not practicing contraception
Active tobacco or alcohol addiction (as assessed by medical caregiver)
Serious comorbid disease which prevents delivery of full treatment including psychiatric disorders, cardiopulmonary disease, etc.
Concomitant use of any trial anticancer therapeutic within 30 days of entry
Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206752

Contacts

Contact: Louis B Harrison, MD

212-844-8087

LHarrison@bethisraelny.org

Locations

United States, New York
Beth Israel Medical Center	Recruiting
New York, New York, United States, 10003
Contact: Margarita Gilyadova 212-844-2028 mgilyado@chpnet.org
Sub-Investigator: Kenneth S Hu, MD

Sponsors and Collaborators

Beth Israel Medical Center

Investigators

Principal Investigator:

Louis B Harrison, MD

Department of Radiation Oncology at Beth Israel Medical Center

More Information

No publications provided

Responsible Party:	beth Israel Medical Center ( Loius Harrison, MD )
Study ID Numbers:	186-03, ETH136-03D
Study First Received:	September 13, 2005
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00206752 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Radiation-Protective Agents
Neoplasms
Neoplasms by Histologic Type
Amifostine
Physiological Effects of Drugs
Neoplasms, Squamous Cell

Carcinoma, Squamous Cell
Protective Agents
Pharmacologic Actions
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on February 08, 2010