Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Reduced-Target Radiotherapy: Experimental group: GTVnx: 69.96 Gy/33 Fr/2.12 Gy; GTVnd: 69.96 Gy/33 Fr/2.12 Gy; CTV1: 60.60 Gy/33 Fr/1.82 Gy; GTV2: No prescription dose (only delineated, actual dose is scattered dose).
Conventional Full-Target Radiotherapy: Control group: GTVnx: 69.96 Gy/33 F/2.12 Gy; GTVnd: 69.96 Gy/33 F/2.12 Gy; CTV1: 59.4 Gy/33 F/1.8 Gy; CTV2: 54 Gy/33 F/1.64 Gy.
Study summary
In order to further verify the effectiveness of the new prevention irradiation model for low-risk areas for nasopharyngeal carcinoma under immunotherapy, our team intends to conduct a non-inferiority clinical trial. The aim is to evaluate the efficacy and safety of two treatment modalities - local region reduced-target radiotherapy versus full-target radiatiotherapy (with/without CTV2) for newly diagnosed distant metastasis nasopharyngeal carcinoma, based on the full-course immunotherapy and full-dose chemotherapy. The primary endpoints are 2-year PFS and the incidence of grade 3 or higher radiation-related adverse events. If non-inferiority is confirmed, a new standard of "immunotherapy combined with reduced-target radiotherapy" will be established, ensuring efficacy while significantly reducing toxicity, and providing a more optimal comprehensive treatment strategy for nasopharyngeal carcinoma.
Eligibility
Primary outcome measure(s)
- 2-year Progression-Free Survival (PFS) — 2 years
The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up. - The incidence rate of radiotherapy-related ≥ grade 3 adverse events — 2 years
Including the evaluation of acute subjective and objective toxic reactions as well as the evaluation of late subjective toxic reactions. The NCI-CTC 5.0 standard and RTOG standard were adopted.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong 519000 Recruiting | Zhuhai | China | Recruiting |
More Ming-Yuan Chen trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07188584 on ClinicalTrials.gov ↗ ← All trials in China