Phase 3
Completed N=111
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Source: ClinicalTrials.gov NCT00274937 ↗Enrolled (actual)
111
Serious AEs
71.2%
Results posted
Jan 2017
Primary outcomePrimary: Two Year Event-free Survival (EFS) — 0.87 Estimated probability
◆ Published Evidence
Highly cited
266citations · ~38 / year
Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16.
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.
Linked Publications (2)
-
Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16.
-
Treatment of Childhood Nasopharyngeal Carcinoma With Induction Chemotherapy and Concurrent Chemoradiotherapy: Results of the Children's Oncology Group ARAR0331 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Two Year Event-free Survival (EFS) |
0.87 | — |
| SECONDARY Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment |
— | — |
| SECONDARY Prognostic Significance of EBV Viral Load |
— | — |
| SECONDARY Predictive Value of the Detection of EBV DNA in the Peripheral Blood |
— | — |
| SECONDARY Protective Effects of Amifostine Assessed Primarily by Sialometry |
4.97; 3.39 | — |
| SECONDARY Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams. |
3.37; 2.30 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00274937) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.