Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma
University of California, San Francisco
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.
Description
PRIMARY OBJECTIVE: I. To measure the proportion of participants alive without progression of disease two years following induction therapy (IT) response-guided IMRT. SECONDARY OBJECTIVES: I. To assess the 1-year rate of progression-free survival (PFS) after IT response-guided IMRT. II. To assess the 1- and 2-year cumulative incidence of locoregional recurrence (LRR) after IT response-guided IMRT. III. To assess the 1- and 2-year cumulative incidence of distant metastasis (DM) after IT response-guided IMRT. IV. To assess the 1- and 2-year rates of overall survival (OS) after IT response-g…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- RadiationIntensity-Modulated Radiation Therapy (IMRT)
Undergo IMRT
- ProcedureRadiographic Imaging
Undergo imaging procedure
- ProcedureBiospecimen Collection
Blood samples will be collected
Location
- University of California, San FranciscoSan Francisco, California