Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06682442
Status
Recruiting
Apply to this trial

Conditions

  • Nasopharyngeal Cancer
  • Nasopharyngeal Cancer Stage
  • Nasopharyngeal Carcinoma
  • Stage III Nasopharyngeal Carcinoma AJCC v8
  • Stage IVA Nasopharyngeal Carcinoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensity-Modulated Radiation Therapy (IMRT) — RADIATION
    Undergo IMRT
  • Radiographic Imaging — PROCEDURE
    Undergo imaging procedure
  • Biospecimen Collection — PROCEDURE
    Blood samples will be collected

Study Details

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.

Key Dates

Start date
Mar 18, 2025
Status verified
Apr 2026
Primary completion
May 31, 2029
Completion
Mar 31, 2032

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT)
    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.
  • Experimental: Arm II (standard IMRT)
    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.

Primary Outcome Measure

Progression-Free Survival Rate (PFS) at 2 years post radiation [ Time Frame: Up to 26 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Jamese Johnson
[email protected]
415-530-9805
[email protected]
877-827-3222
Sue Yom, MD, PhD (PRINCIPAL_INVESTIGATOR)

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