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Eligibility
for people ages up to 18 years
Location
at San Francisco, California and other locations
Dates
study started

Description

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 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.

Official Title

Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study

Details

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 by concurrent chemoradiotherapy and amifostine.

SECONDARY OBJECTIVES:

I. Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children.

II. Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma.

III. Determine the incidence of NUT rearrangements in childhood nasopharyngeal carcinoma.

IV. Determine the radioprotective effect of amifostine when given daily prior to radiation therapy.

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.

Keywords

Stage I Lymphoepithelioma of the Nasopharynx Stage I Squamous Cell Carcinoma of the Nasopharynx Stage II Lymphoepithelioma of the Nasopharynx Stage II Squamous Cell Carcinoma of the Nasopharynx Stage III Lymphoepithelioma of the Nasopharynx Stage III Squamous Cell Carcinoma of the Nasopharynx Stage IV Lymphoepithelioma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx Cisplatin Fluorouracil Amifostine

Eligibility

For people ages up to 18 years

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

Locations

  • Kaiser Permanente-Oakland
    Oakland, California, 94611, United States
  • Children's Hospital Central California
    Madera, California, 93636-8762, United States
  • Lucile Packard Children's Hospital Stanford University
    Palo Alto, California, 94304, United States
  • Children's Hospital Los Angeles
    Los Angeles, California, 90027, United States
  • Southern California Permanente Medical Group
    Downey, California, 90242, United States
  • David Geffen School of Medicine at UCLA
    Los Angeles, California, 90095, United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas, Nevada, 89106, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT00274937
Phase
Phase 3
Study Type
Interventional
Last Updated
November 1, 2016