Status:
COMPLETED
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7
Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the response rate, overall survival, and event-free survival of children with advanced nasopharyngeal carcinoma who are treated with induction chemotherapy followed b...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
- Stage I-IV disease
- Newly diagnosed disease
- Performance status
- Patients ≤ 16 years of age: Lansky 60-100%
- Patients \> 16 years of age: Karnofsky 60-100%
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
- Creatinine based on age/gender as follows:
- No greater than 0.4 mg/dL (for patients 1 month to \< 6 months of age)
- No greater than 0.5 mg/dL (for patients 6 months to \< 1 year of age)
- No greater than 0.6 mg/dL (for patients 1-2 years of age)
- No greater than 0.8 mg/dL (for patients \< 6 years of age)
- No greater than 1.0mg/dL (for patients 6 to \< 10 years of age)
- No greater than 1.2 mg/dL (for patients 10 to \< 13 years of age)
- No greater than 1.4 mg/dL (for female patients 13 to ≥ 16 years of age)
- No greater than 1.5 mg/dL (for male patients 13 to \< 16 years of age)
- No greater than 1.7 mg/dL (for male patients ≥ 16 years of age)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- AST or ALT \< 2.5 times ULN for age
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
Exclusion
Key Trial Info
Start Date :
February 20 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00274937
Start Date
February 20 2006
End Date
September 30 2022
Last Update
October 25 2022
Active Locations (109)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
4
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591