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Type(s) of Cancer
Nasopharyngeal
Study Phase
Phase 3
Study Completion Date
December 2014
NCT00274937Uploaded 07-09-2021
Access via NCI by Request
PDS UID: nci-data-474
Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Provider Information
Provider Data DescriptionNCT00274937-D1-Dataset (Main) This dataset provides data required for reproducing all quantitative statements in the manuscript except for the toxicity table presented as Table A1 in the APPENDIX. Blanks represent missing data or not applicable for analysis. All patients are eligible. There is one row per patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsStage 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
Intervention TypeDrug: Amifostine
Drug: Cisplatin
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis
Radiation: Radiation Therapy
Drug(s)Drug: Amifostine
Drug: Cisplatin
Drug: Fluorouracil
Total Enrolled111
RandomizationNon-Randomized
Blinding MethodNone (Open Label)
Arms InterventionStratum I (radiotherapy, chemoprotective agent) - Experimental
Stratum II (chemotherapy, chemoprotective agent, radiotherapy) - Experimental
Secondary IDNCI-2009-00412
PubMed (PMID)31657981
31553639
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Age Range18 Years and younger (Child, Adult)
Files: NCT00274937-D1
Data DictionaryNCT00274937-D1-Data-Dictionary_0.pdf
DATANCT00274937-D1-Dataset.csv
OTHERREADME.pdf
Files: NCT00274937-D2
Data DictionaryNCT00274937-D2-Data-Dictionary_0.pdf
DATANCT00274937-D2-Dataset.csv
OTHERREADME.pdf
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