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Optimization of Cervical Nodal CTV for Early and Medium Stage NPC

NCT05145660 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2022-09-27

No results posted yet for this study

Summary

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

intensity-modulated radiotherapy (IMRT) with reduced-volume

PGTVnx: 69.9Gy/2.12Gy/33f GTVrpn: 69.9Gy/2.12Gy/33f GTVnd: 69.9Gy/2.12Gy/33f GTVnd-suspicious: 60.06Gy/1.82Gy/33f PTV1: 60.06Gy/1.82Gy/33f PTV2: 50.96Gy/1.82Gy/28f

DRUG

Chemotherapy

Concurrent cisplatin (100 mg/m², d1-3, Q3w, maximum to three cycles); The application of induction chemotherapy and consolidation chemotherapy is dependent on the physician's discretion.

Sponsors & Collaborators

  • Jun-Lin Yi, MD

    lead UNKNOWN

Principal Investigators

  • Junlin Yi · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05145660 on ClinicalTrials.gov