NCT06682442 Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
| NCT ID | NCT06682442 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2029-05-31 |
Trial Parameters
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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.
Eligibility Criteria
Inclusion Criteria: * 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 * M