Clinical trial NCT00274937
Conditions: Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7 Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage II Nasopharyngeal Undifferentiated Carcinoma AJCC v7 Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7 Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7
Sponsor: Children's Oncology Group
Start date: 2006-02-20; Completion date: 2022-09-30
Enrollment: 111 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

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 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.

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 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.

Arms: arm 1: Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy. arm 2: 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 radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as before.
Interventions: intervention 1: Amifostine intervention 2: Cisplatin intervention 3: Fluorouracil intervention 4: Laboratory Biomarker Analysis intervention 5: Radiation Therapy
Intervention descriptions: intervention 1: Given subcutaneously intervention 2: Given IV intervention 3: Given IV intervention 4: Correlative studies intervention 5: Undergo radiotherapy

Protocol documents: