Chemotherapy and Radiation Based on EBV DNA for Nasopharyngeal Cancer

Recruiting in Palo Alto (17 mi)

+221 other locations

Overseen byNancy Lee

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: NRG Oncology

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests different combinations of chemotherapy drugs and radiation therapy for advanced nasopharyngeal cancer. It targets patients whose cancer has not spread beyond the local region. The treatment works by killing cancer cells or stopping their growth using powerful drugs and radiation. Previous studies have shown a survival benefit using a combination of these treatments for nasopharyngeal carcinoma.

Research Team

Nancy Lee

Principal Investigator

NRG Oncology

Eligibility Criteria

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.

Inclusion Criteria

Alkaline phosphatase ≤ 1.5 x institutional upper limit of normal

I have been mostly active and able to carry out all pre-disease activities without restriction in the last 3 weeks.

Platelets ≥ 100,000 cells/mm^3

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Exclusion Criteria

I have been cancer-free for at least 3 years.

Severe, active co-morbidity

Patients with hearing loss requiring a hearing aid or intervention

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Treatment Details

Interventions

Cisplatin (Alkylating agents)
Fluorouracil (Anti-metabolites)
Gemcitabine Hydrochloride (Anti-metabolites)
Intensity-Modulated Radiation Therapy (Radiation)
Paclitaxel (Mitotic Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Cisplatin is already approved in Canada, Japan for the following indications: