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Alkylating agents
Stratum II (chemotherapy, chemoprotective agent, radiotherapy) for Nasopharyngeal Carcinoma
Phase 3
Waitlist Available
Led By Carlos Rodriguez-Galindo, MD
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
Stage I-IV disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is studying radiation therapy, amifostine, and chemotherapy as a possible treatment for nasopharyngeal cancer.
Eligible Conditions
- Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two year after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two year after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Two Year Event-free Survival (EFS)
Secondary outcome measures
Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment
Predictive Value of the Detection of EBV DNA in the Peripheral Blood
Prognostic Significance of EBV Viral Load
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Stratum II (chemotherapy, chemoprotective agent, radiotherapy)Experimental Treatment5 Interventions
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.
Group II: Stratum I (radiotherapy, chemoprotective agent)Experimental Treatment3 Interventions
Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Fluorouracil
2014
Completed Phase 3
~11540
Cisplatin
2013
Completed Phase 3
~1940
Amifostine
2006
Completed Phase 3
~390
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,289 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,164 Total Patients Enrolled
70 Trials studying Nasopharyngeal Carcinoma
13,790 Patients Enrolled for Nasopharyngeal Carcinoma
Carlos Rodriguez-Galindo, MDPrincipal InvestigatorChildren's Oncology Group
6 Previous Clinical Trials
1,913 Total Patients Enrolled
Frequently Asked Questions
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