Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
2 other identifiers
interventional
66
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2024
CompletedFirst Posted
Study publicly available on registry
November 12, 2024
CompletedStudy Start
First participant enrolled
March 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2032
May 1, 2026
April 1, 2026
4.2 years
November 7, 2024
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival Rate (PFS) at 2 years post radiation
PFS is defined as the proportion of participants alive without progression of disease from the first day of radiotherapy to progression or death by any cause, whichever occurs first, assessed up to 2 years after the last day of radiation therapy. The Kaplan-Meier method will be used to estimate the PFS rate along with a 90% confidence interval.
Up to 26 months
Secondary Outcomes (10)
Progression-Free Survival Rate (PFS) at 1 year post radiation
Up to 14 months
Locoregional recurrence rate (LRR) at 1 year post radiation
Up to 14 months
Locoregional recurrence rate (LRR) at 2 years post radiation
Up to 26 months
Incidence of Distant metastasis (DM) at 1 year post radiation
Up to 14 months
Incidence of Distant metastasis (DM) at 2 years post radiation
Up to 26 months
- +5 more secondary outcomes
Study Arms (2)
Arm I (de-escalated Intensity Modulated Radiation Therapy (IMRT)
EXPERIMENTALParticipants 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.
Arm II (standard IMRT)
EXPERIMENTALPatients 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.
Interventions
Undergo IMRT
Undergo imaging procedure
Blood samples will be collected
Eligibility Criteria
You may qualify if:
- 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.
- Stage III-IVA disease (American Joint Committee on Cancer \[AJCC\], 8th edition \[ed.\]) with no evidence of distant metastasis at the time of diagnosis based upon all 3 of the following minimum diagnostic workup criteria:
- History/physical examination by a medical oncologist or clinical oncologist or radiation oncologist or otolaryngology (ENT);
- Evaluation of tumor extent with either one of the following:
- MRI with contrast of the face, nasopharynx, and neck or CT with contrast of the face, nasopharynx and neck with ≤ 3 mm contiguous slices and bone windows to evaluate base of skull involvement; or
- MRI of the nasopharynx and PET/CT (with contrast) of the neck
- Imaging to rule out distant metastasis:
- CT scan with contrast of the chest and abdomen (required) and the pelvis (optional) or a total body PET/CT scan (non-contrast PET/CT is acceptable); and
- Only if clinically indicated: Bone scan only when there is suspicion of bone metastases (a PET/CT scan can substitute for the bone scan)
- Started or planning to start platinum-based induction systemic therapy.
- Planning to receive intensity modulated radiation therapy (IMRT) with concurrent, platinum-based systemic therapy during radiation.
- Use of adjuvant (post-chemoradiation) immunotherapy is permitted.
- Age \>=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%).
- +6 more criteria
You may not qualify if:
- Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy (IT); note that prior chemotherapy for a different cancer is permitted
- Prior radiotherapy to the nasopharynx or surrounding involved areas that would result in overlap of radiation therapy fields
- Has participated in a study of an investigational product and received treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose of treatment
- Severe, active comorbidity, defined as any of the following:
- Major medical or psychiatric illness that, in the treating investigator's opinion, would interfere with the completion of therapy and follow-up or interfere with a full understanding of the risks and potential complications of the therapy
- Unstable angina, congestive heart failure, or peripheral vascular disease requiring hospitalization within the last 12 months; or other cardiac compromise that in the judgment of the treating investigator will preclude safe administration of study treatment
- Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within 30 days prior to registration, or which would preclude safe administration study therapy in the opinion of the treating investigator
- Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Because the radiation therapy used in this trial is known to be teratogenic, individuals of child-bearing potential must have documentation in their medical record of a negative pregnancy test
- \* A female participant is considered to NOT be of child-bearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria:
- Has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause)
- Has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries)
- Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities or interfere with participant safety or study endpoints
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sue Yom, MD, PhD
University of California, San Francisco
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2024
First Posted
November 12, 2024
Study Start
March 18, 2025
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
March 31, 2032
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share