Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer

Basic Trial Information

Objectives

Primary

1. 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.

Secondary

1. Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children.
2. Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma.
3. Determine the incidence of NUT rearrangements in childhood nasopharyngeal carcinoma.
4. Determine the radioprotective effect of amifostine when given daily prior to radiation therapy.

Entry Criteria

Disease Characteristics:

• Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
  • Stage I-IV disease
  • Newly diagnosed disease

Prior/Concurrent Therapy:

• No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma

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/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 1.0 mg/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

Expected Enrollment

A total of 160 patients will be accrued for this study.

Outcomes

Disease-free survival at 2 years after treatment
Response rate at 12 weeks after induction

Predictive value of Epstein-Barr virus (EBV) DNA as measured by quantitative detection at 2 years after treatment

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.

• Stratum II:
  • 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 cisplatin IV over 6 hours on days 1 and 22 (2 courses).

After completion of study treatment, patients are followed periodically for 10 years.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Carlos Rodriguez-Galindo, MD, Protocol chair		Ph: 617-632-4580; 866-790-4500

Registry Information
Official Title		Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy
Trial Start Date		2006-02-20
Trial Completion Date		2009-06-04 (estimated)
Registered in ClinicalTrials.gov		NCT00274937
Date Submitted to PDQ		2005-09-15
Information Last Verified		2012-02-08
NCI Grant/Contract Number		CA98543

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