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Radiation

Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT) for Nasopharyngeal Carcinoma

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 histologically or cytologically confirmed (from primary lesion and/or lymph nodes) nasopharyngeal carcinoma.

* Participants must have Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma, defined as detectable (\> 0 copies/mL) circulating plasma EBV DNA on a qualitative or quantitative polymerase chain reaction (PCR)-based test.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 26 months

Awards & highlights

No Placebo-Only Group

Summary

This clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy \[IMRT\]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Intensity-modulated radiation therapy (IMRT) is an advanced form of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Radiation therapy sometimes causes unwanted symptoms or side effects, including late effects such as hearing loss and dental problems. The severity of the side effects is related to the radiation dose received and the amount of tissue that received radiation. De-escalation IMRT uses lower doses of radiation based on a good response to induction chemotherapy. Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer.

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

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

~2020

0 / 10Eligibility criteria met