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Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma

Study acronym: CTV-MARGIN-NPC
StatusRecruiting
PhasePhase 3
Started2026-07-24
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 days later Jun 30, 2029 → Jul 30, 2029
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Sun Yat-sen University

Amendment history

2026-08-16
Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v2
Primary endpoint(s) modified1 entry, revised
WasLocal failure-free survival (LFFS)
NowLocal relapse-free survival (LRFS)
Study sites5→7
InterventionsComprehensive Therapy Based on Tumor Stage (Procedure), IMRT with Consensus Primary Clinical Target Volume (Radiation), IMRT with…→Comprehensive Therapy Based on Tumor Stage (Procedure), IMRT with Consensus Primary Clinical Target Volume (Radiation), IMRT with Primary…
Secondary endpoints8 entries, revised
Distant failuremetastasis-free survival (DFFSDMFS) Locoregional failurerelapse-free survival (LRFFS) Regional failurerelapse-free survival (RFFSRRFS)
Study description-594 characters
TheThis goalsmulticenter, ofprospective, thisrandomized clinicalphase 3 trial are:aims to evaluate a) To confirm whether the local failuremargin-free survival of patients with nasopharyngeal carcinoma whoseexpansion-based primary clinical target volume is(CTVp) delineateddelineation basedstrategy onin marginpatients expansionwith newly diagnosed non-metastatic nasopharyngeal carcinoma (NPC). The primary objective is to demonstrate non-inferiorinferiority toof this CTVp approach compared with the localconsensus failure-freeCTVp survivaldefined of patients whose primary clinical target volume is [...] [...]
2026-07-25
Study Status, Arms and Interventions, Contacts/Locations v1
Recruitment opened
Primary completion pushed: 2029-06-30 → 2029-07-30
Completion pushed: 2034-06-30 → 2034-07-30
Start dateestimated 2026-07-01→confirmed 2026-07-24
Study sites4→5
2026-06-16
Original filing
This is a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed non-metastatic nasopharyngeal carcinoma.
Trial Details
NCT Number NCT07661771
Lead Sponsor Sun Yat-sen University
Conditions Non-metastatic Nasopharyngeal Carcinoma
Enrollment 568 participants
Start Date 2026-07-24
Primary Completion 2029-07-30 (estimated)
Study Completion 2034-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-19