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Hypofraction Radiotherapy for Locally Advanced Non-small Cell Lung Cancer

NCT05269485 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-06-25

No results posted yet for this study

Summary

Definitive concurrent chemoradiotherapy followed by durvalumab (Pacific protocol) has been the standard modality for stage III locally advanced non-small cell lung cancer. In spite of the median overall survival of 47.5 months, there still existed 38.5% and 6.9% patients who finally developed intra-thorax and extra-thorax recurrence respectively in long-term follow-up. The relatively low local control rate has been the bottleneck for further improvement of overall survival. Hypofraction radiotherapy has been validated to be able to increase the local control rate in two prospective trials. Therefore, this trial is designed to explore the safety and primary efficacy of hypofraction radiotherapy followed by immune checkpoint inhibitors for stage III locally advanced non-small cell lung cancer.

Conditions

Interventions

RADIATION

High-dose fractionated radiotherapy

Patients in this arm would receive high-dose fractionated radiotherapy with 60-68Gy/15-17f with one-year immunotherapy maintenance.

RADIATION

Low-dose fractionated radiotherapy

Patients in this arm would receive high-dose fractionated radiotherapy with 48Gy/15-12f with one-year immunotherapy maintenance.

Sponsors & Collaborators

  • Anhui Provincial Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05269485 on ClinicalTrials.gov