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NCT05145660

Optimization of Cervical Nodal CTV for Early and Medium Stage NPC

Recruiting now Phase 3 Last updated 27 September 2022
What this trial tests

Phase 3 trial testing intensity-modulated radiotherapy (IMRT) with reduced-volume in Nasopharyngeal Carcinoma in 414 participants. Currently enrolling.

Timeline
1 September 2022
Primary endpoint
31 August 2027
31 August 2027

Quick facts

Lead sponsorJun-Lin Yi, MD
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment414
Start date1 September 2022
Primary completion31 August 2027
Estimated completion31 August 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jun-Lin Yi, MD

Who can join

Adults 18 to 75, any sex, with Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Current radiotherapy guidelines and consensus statements uniformly recommend elective region irradiation (ERI) as the standard strategy for nasopharyngeal carcinoma (NPC). However, given the scarcity of skip-metastasis, the improved assessment accuracy of nodal involvement, and the striking advancements in chemotherapy for NPC, a one-fits-all delineation scheme for clinical target volumes for the nodal region (CTVn) may not be appropriate anymore, and modifications of the CTVn delineation strategy may be warranted. Involved site irradiation (ISI) covering merely the initially involved nodal site and potential extranodal extension has been confirmed to be as effective as ERI with decreased radiation-related toxicities in some malignancies, but has not yet been investigated in NPC. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of ISI with conventional ERI in NPC patients with a limited nodal burden.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The evolution of prophylactic neck irradiation in nasopharyngeal carcinoma: Changing concepts and irradiation ranges.
    Liao W, Zhao Y, Zhang S. · · 2025 · cited 2× · PMID 41163975 · DOI 10.1002/pro6.70007
  2. Involved site radiation therapy in stage I-III nasopharyngeal carcinoma with limited lymph node burden (ISRT-NPC) or elective region irradiation: a study protocol for a multicenter non-inferiority randomized controlled phase III clinical trial.
    Liu Y, Han Y, Liu F, Hu D, et al · · 2023 · PMID 37537541 · DOI 10.1186/s12885-023-11212-7

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Other recruiting trials for Nasopharyngeal Carcinoma

Currently open trials in the same condition.

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