Phase III of Unilateral Neck Irradiation With Amifostine in Patients With SCC of the Head and Neck
Information source: Beth Israel Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Squamous Cell Carcinoma of the Head and Neck
Intervention: amifostine plus radiation therapy (amifostine arm) (Radiation); definitive external beam radiation in the ipsilateral neck (Radiation)
Phase: Phase 3
Status: Recruiting
Sponsored by: Beth Israel Medical Center Official(s) and/or principal investigator(s):
Louis B Harrison, MD, Principal Investigator, Affiliation: Department of Radiation Oncology at Beth Israel Medical Center
Overall contact:
Louis B Harrison, MD, Phone: 212-844-8087, Email: LHarrison@bethisraelny.org
Summary
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.
Clinical Details
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.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: FACT (head and neck);Xerostomia related Quality of Life Questionnaire
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Louis B Harrison, MD, Phone: 212-844-8087, Email: LHarrison@bethisraelny.org
Beth Israel Medical Center, New York, New York 10003, United States; Recruiting
Margarita Gilyadova, Phone: 212-844-2028, Email: mgilyado@chpnet.org
Kenneth S Hu, MD, Sub-Investigator
Additional Information
Starting date: August 2004
Ending date: August 2011
Last updated: March 17, 2009
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