NCT05674305

Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy

A Multicenter, Randomized, Non-inferior Phase III Study of Radiotherapy Alone Versus Concurrent Chemo-radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Complete Remission of EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Radiotherapy	IMRT for primary and regional field
DRUG	Cisplatin	Cisplatin 80mg/m2, 21days/cycle, 2 cycles

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2027-01-01
• First posted: 2023-01-06
• Last updated: 2023-01-10

Locations

1 site across 1 country: China