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Alkylating agents

Chemotherapy and Radiation Based on EBV DNA for Nasopharyngeal Cancer

Phase 2 & 3
Waitlist Available
Led By Nancy Lee
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage II-IVB disease with no evidence of distant metastasis
Biopsy proven diagnosis of cancer of the nasopharynx
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights

Study Summary

This trial will test whether a blood biomarker can help doctors identify which patients will benefit from different types of chemotherapy after radiation therapy for nasopharyngeal cancer.

Who is the study for?
This trial is for patients with Stage II-IVB nasopharyngeal cancer without distant metastasis. They must have detectable EBV DNA in their plasma, adequate organ function, and agree to use birth control if applicable. Exclusions include major illness affecting trial participation, recent heart issues or infections requiring IV antibiotics, prior malignancies within 3 years (except certain skin cancers), previous chemotherapy or radiotherapy for the study cancer, severe neuropathy, AIDS, and significant co-morbidities.Check my eligibility
What is being tested?
The trial tests whether cisplatin and fluorouracil are more effective than gemcitabine hydrochloride and paclitaxel following radiation therapy in treating nasopharyngeal cancer based on EBV DNA levels post-standard treatment. It's a randomized phase II/III study where treatments vary depending on the presence of EBV DNA after initial chemo-radiation therapy.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting from chemotherapy drugs like cisplatin and fluorouracil; fatigue from radiation; possible allergic reactions to medications; blood count changes leading to increased infection risk; liver function alterations; hearing loss primarily if sensorineural in nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is between stage II and IVB and has not spread far.
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My cancer in the upper part of my throat has been confirmed by a biopsy.
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My kidney function is within the normal range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS) (Undetectable Plasma EBV DNA Cohort Phase III)
Progression-free survival (PFS) (Detectable Plasma EBV DNA Cohort Phase II)
Secondary outcome measures
Changes in QOL (hearing) as assessed by the Hearing Handicap Inventory for the Elderly-Screening version (HHIE-S) (Phase II and III)
Changes in QOL (peripheral neuropathy) as assessed by the FACT-Taxane (Phase II and III)
Changes in pure tone audiometry (Phase II and III)
+10 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (chemoradiation, observation)Experimental Treatment5 Interventions
Patients undergo clinical observation.
Group II: Arm II (chemoradiation, gemcitabine hydrochloride, paclitaxel)Experimental Treatment6 Interventions
Patients receive GT regimen comprising paclitaxel IV over 1 hour and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 at least 4 weeks after completion of IMRT. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Group III: Arm I (chemoradiation, cisplatin, fluorouracil)Active Control5 Interventions
Patients receive PF regimen comprising cisplatin IV over 60-120 minutes and fluorouracil IV over 96 hours continuously beginning at least 4 weeks after completion of IMRT. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Group IV: Arm III (chemoradiation, cisplatin, fluorouracil)Active Control5 Interventions
Patients receive PF regimen as in Arm I of Phase II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,167 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,468 Total Patients Enrolled
Nancy LeePrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02135042 — Phase 2 & 3
EBV Infection Research Study Groups: Arm I (chemoradiation, cisplatin, fluorouracil), Arm II (chemoradiation, gemcitabine hydrochloride, paclitaxel), Arm III (chemoradiation, cisplatin, fluorouracil), Arm IV (chemoradiation, observation)
EBV Infection Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02135042 — Phase 2 & 3
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02135042 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of cancer has Cisplatin been most effective in combating?

"Cisplatin is a chemotherapy medication that is useful in treating metastatic bladder cancer, as well as other diseases like small cell lung cancer and advanced testicular cancer."

Answered by AI

Are there any other research hospitals conducting this trial in the metropolitan area?

"There are presently 100 sites hosting this clinical trial. While some of these are located in Livonia, Strongsville and Cincinnati, there are also 100 other locations. If you enroll in the trial, try to select the clinic nearest you to limit travel."

Answered by AI

Could you please list other times when Cisplatin has been used in research?

"First explored as a treatment in 1997 at City of Hope Comprehensive Cancer Center, cisplatin has undergone 3,550 completed studies. As of now, 1,819 live clinical trials are using this medication with a large portion of them based in Cincinnati, Michigan."

Answered by AI

Who else is applying?

What state do they live in?
Utah
Texas
Georgia
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
2014. "Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02135042.
All > Ebv > Paid Studies Delaware
~102 spots leftby Feb 2026
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