Actively Recruiting
Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
Led by University of California, San Francisco · Updated on 2026-05-01
66
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of induction chemotherapy response-guided radiation therapy in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. This trial compares standard intensity-modulated radiation therapy (IMRT) with a de-escalated version of IMRT, which uses lower radiation doses based on a patient's response to chemotherapy. The study aims to see if this lower dose approach is as effective as the standard treatment while potentially reducing side effects like hearing loss and dental problems. Participants receive radiation therapy five days a week for up to seven weeks, either with standard IMRT or de-escalated IMRT depending on their response to induction chemotherapy. Those showing partial radiographic response are assigned to the de-escalated radiation group, while patients with stable or progressive disease receive standard radiation. Throughout the trial, patients undergo various imaging scans such as CT, MRI, PET, PET/CT, and bone scans, along with blood sample collection. Participants are monitored closely during and after treatment, with follow-up visits scheduled at three months post-treatment and then every six months for up to ten years. The study measures outcomes like progression-free survival, overall survival, rates of cancer recurrence, and distant metastasis, as well as acute and late side effects. Researchers also assess quality of life, fatigue, treatment breaks, hospitalizations, and the relationship between EBV DNA levels and treatment response. Safety and long-term effects are tracked over several years to evaluate the impact of these radiation strategies.
CONDITIONS
Brief Title
Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed nasopharyngeal carcinoma
- Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma with detectable plasma EBV DNA
- Stage III to IVA disease without distant metastasis based on specified imaging and clinical evaluations
- Started or planning to start platinum-based induction systemic therapy
- Planning to receive intensity modulated radiation therapy (IMRT) with concurrent platinum-based systemic therapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- HIV-infected individuals on effective anti-retroviral therapy are eligible
- For chronic hepatitis B: must be on suppressive therapy if indicated
- For hepatitis C: must be currently treated or cured
- Prior or concurrent malignancies allowed if they do not interfere with study assessments
- Willingness to use adequate contraception during study and for 60 days after radiation
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior systemic chemotherapy for nasopharyngeal carcinoma other than induction chemotherapy
- Prior radiotherapy to nasopharynx or surrounding areas causing overlap with study radiation fields
- Participation in an investigational drug or device study within 4 weeks before treatment
- Severe active comorbidities including major medical or psychiatric illness interfering with therapy or understanding
- Unstable angina, congestive heart failure, or vascular disease requiring hospitalization within 12 months
- Recent COPD exacerbation or respiratory illness requiring hospitalization within 30 days
- Active, untreated infections requiring intravenous antibiotics at registration
- Negative pregnancy test required for individuals of child-bearing potential
- Females not of child-bearing potential defined by menopause or surgical sterilization
- Conditions or social circumstances impairing compliance or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 weeks
Participants receive intensity-modulated radiation therapy (IMRT) daily, 5 days a week, for up to 7 weeks. Participants are assigned to either de-escalated or standard IMRT based on their response to induction chemotherapy. Imaging scans and blood samples are collected throughout treatment to monitor response and safety.
Weekly visits for up to 7 weeks
Duration - Up to 10 years
After completing treatment, participants are followed up to monitor disease progression, survival, and late effects. Follow-up visits occur frequently at first and then every 6 months for up to 10 years, including imaging and blood sample assessments.
1 visit at 3 months, then visits every 6 months for up to 10 years
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
J
Jamese Johnson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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