Phase 3
N=111
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
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
Bottom Line
View on ClinicalTrials.gov: NCT00274937 ↗Enrolled (actual)
111
Serious AEs
71.2%
Results posted
Jan 2017
Primary outcome: Primary: Two Year Event-free Survival (EFS) — 0.87 Estimated probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amifostine (Drug); Cisplatin (Drug); Fluorouracil (Drug); Laboratory Biomarker Analysis (Other); Radiation Therapy (Radiation)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Dec 2014
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 | — |
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.
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). 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.