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Radiation

Radiation Therapy for Nasopharyngeal Cancer

N/A

Waitlist Available

Led By Sue Yom, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Participants must have histologically or cytologically confirmed nasopharyngeal carcinoma

Must not have

Severe, active comorbidity including major medical or psychiatric illness, unstable angina, congestive heart failure, peripheral vascular disease, COPD exacerbation, active untreated infection

Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 26 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a new type of radiation therapy, de-escalated IMRT, to the standard IMRT in patients with EBV-associated nasopharyngeal cancer. De-escalated IM

Who is the study for?

This trial is for individuals with nasopharyngeal cancer linked to the Epstein-Barr virus. Participants should respond well to initial chemotherapy, as their subsequent radiation therapy dose will be adjusted based on this response.

What is being tested?

The study compares two radiation therapies in EBV-associated nasopharyngeal cancer patients: standard Intensity-Modulated Radiation Therapy (IMRT) and a lower-dose IMRT guided by how well patients respond to initial chemotherapy.

What are the potential side effects?

Potential side effects include damage to healthy tissue near the tumor, which can lead to hearing loss and dental problems. The severity of side effects may vary depending on the radiation dose received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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My cancer diagnosis of the nasopharynx was confirmed through lab tests.

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I have completed treatment with platinum-based chemotherapy.

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I am 18 years old or older.

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I am being treated for or have been cured of hepatitis C.

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My cancer is linked to the Epstein Barr virus and tests show EBV DNA in my blood.

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My cancer was diagnosed at Stage III-IVA without spread to distant parts of my body.

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I am scheduled for IMRT with platinum-based therapy during radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe, active illnesses like heart problems, serious lung issues, or untreated infections.

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I have had chemotherapy for nasopharyngeal cancer, but not as initial treatment.

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I have had radiation therapy to my nasopharynx or nearby areas with overlapping treatment fields.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival Rate (PFS) at 2 years post radiation

Secondary study objectives

Incidence of Distant metastasis (DM) at 1 year post radiation

Incidence of Distant metastasis (DM) at 2 years post radiation

Locoregional recurrence rate (LRR) at 1 year post radiation

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (standard IMRT)Experimental Treatment3 Interventions

Patients undergo standard IMRT QD 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.

Group II: Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT)Experimental Treatment3 Interventions

Participants undergo de-escalated IMRT every day (QD) 5 days a week for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, PET, PET/CT, CT, and/or bone scans as well as providing blood samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

0 / 11Eligibility criteria met