Cancer Radiation Therapy |
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Clinical Trial: Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) December 2005
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.
PURPOSE: This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Nasopharyngeal Cancer Oral Complications of Chemotherapy and Head and Neck Radiation | Drug: amifostine trihydrate Drug: cisplatin Drug: fluorouracil Procedure: chemotherapy Procedure: complications of therapy assessment/management Procedure: neoadjuvant therapy Procedure: radiation therapy Procedure: radioprotection Procedure: supportive care/therapy | Phase III |
MedlinePlus related topics: Cancer; Head and Neck Cancer; Throat Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Study of Radiotherapy and Amifostine OR Neoadjuvant Induction Chemotherapy Followed By Consolidation Chemoradiotherapy and Amifostine in Children With Newly Diagnosed Nasopharyngeal Carcinoma
OBJECTIVES:
Primary
- Determine the response rate, overall survival, and event-free survival of children with advanced nasopharyngeal carcinoma who are treated with induction chemotherapy followed by concurrent chemoradiotherapy and amifostine.
- Determine the radioprotective effect of amifostine when given daily prior to radiation therapy.
Secondary Objectives
- Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children.
- Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma.
- Determine the incidence of NUT rearrangements in childhood nasopharyngeal carcinoma.
OUTLINE: This is a nonrandomized, multicenter study. Patients are stratified according to stage of disease (I or IIA [stratum I] vs IIB-IV [stratum II]).
- Stratum I: Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.
- Induction therapy (weeks 1-9): Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease proceed to consolidation therapy.
- Consolidation therapy (weeks 10-18): Patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as in induction therapy.
After completion of study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.
Eligibility
DISEASE CHARACTERISTICS:
- Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
- Stage I-IV disease
- Newly diagnosed disease
PATIENT CHARACTERISTICS:
- 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 OR
- Creatinine based on age as follows:
- No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
- No greater than 1.0 mg/dL (for patients 6-10 years of age)
- No greater than 1.2 mg/dL (for patients 11-15 years of age)
- No greater than 1.5 mg/dL (for patients > 15 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
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
Location and Contact Information
Carlos Rodriguez-Galindo, MD, Study Chair, St. Jude Children''''s Research Hospital
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: January 10, 2006
Record first received: January 10, 2006
ClinicalTrials.gov Identifier: NCT00274937
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-17

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