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RECRUITING
NCT05674305
PHASE3

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

366

Start Date

2022-01-01

Completion Date

2027-01-01

Last Updated

2023-01-10

Healthy Volunteers

No

Interventions

DRUG

Radiotherapy

IMRT for primary and regional field

DRUG

Cisplatin

Cisplatin 80mg/m2, 21days/cycle, 2 cycles

Locations (1)

Fudan Universtiy Shanghai Cancer Centre

Shanghai, Shanghai Municipality, China