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Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma

NCT06516133 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2024-07-23

No results posted yet for this study

Summary

In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy

Radiation: Complete the full course of radiotherapy using the original treatment plan. Planning target volume (PTV) margin: 3mm;

DRUG

Chemotherapy

Chemotherapy: If given, platinum-based.

RADIATION

Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy

Radiation: During the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of patients. planning target volume (PTV) margin: smaller.

DRUG

Chemotherapy

Chemotherapy: If given, platinum-based

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2030-12-31
Completion
2030-12-31

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 NCT06516133 on ClinicalTrials.gov