Overview

This trial is active, not recruiting.

Conditions 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
Treatments amifostine trihydrate, fluorouracil, cisplatin, laboratory biomarker analysis, radiation therapy
Phase phase 3
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date February 2006
End date December 2014
Trial size 111 participants
Trial identifier NCT00274937, ARAR0331, CDR0000454849, COG-ARAR0331, NCI-2009-00412, U10CA098543

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo radiation therapy 5 days a week for 8 weeks. Patients also receive amifostine trihydrate subcutaneously on the same days they undergo radiation therapy.
amifostine trihydrate ethiofos
Given subcutaneously
laboratory biomarker analysis
Correlative studies
radiation therapy irradiation
Undergo radiotherapy
(Experimental)
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 weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.
amifostine trihydrate ethiofos
Given subcutaneously
fluorouracil 5-fluorouracil
Given IV
cisplatin CACP
Given IV
laboratory biomarker analysis
Correlative studies
radiation therapy irradiation
Undergo radiotherapy

Primary Outcomes

Measure
Disease-free survival (EFS)
time frame: At 2 years

Secondary Outcomes

Measure
Predictive value of Epstein-Barr virus (EBV) DNA as measured by quantitative detection at 2 years after treatment
time frame: Not Provided
Prognostic significance of EBV viral load
time frame: At baseline
Predictive value of the detection of EBV DNA in the peripheral blood
time frame: Up to 6 years
Protective effects of amifostine assessed primarily by sialometry
time frame: At baseline and up to 12 weeks after completion of radiotherapy

Eligibility Criteria

Male or female participants up to 18 years old.

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

Additional Information

Official title Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Principal investigator Carlos Rodriguez-Galindo, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Children's Oncology Group.