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Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC

NCT05548504 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2022-09-21

No results posted yet for this study

Summary

Aim To test if proton therapy can improve survival compared to photon therapy in patients with locally advanced NSCLC who are not candidates for standard definitive chemo-radiotherapy.

Hypothesis The trial hypothesis is that proton therapy is less toxic than photon therapy in fragile patients and that this difference will mitigate to a difference in overall survival.

Design Multicentre, randomized phase II study 1:1 Sample size 182 patients (91 in each arm) Treatment Radiotherapy (inhomogeneous dose distribution) 50 Gy/ 24 fraction Endpoint Primary: Overall survival at 12 months Secondary: progression free survival, time to loco-regional and distant failure, pattern of failure, acute and late toxicity, quality of life, patient compliance.

Conditions

  • Non-small Cell Lung Cancer Stage III
  • Radiotherapy Side Effect
  • Frailty

Interventions

RADIATION

Photon

50-66Gy/ 24 fractions, inhomogeneous dose distribution photon therapy

RADIATION

Proton

50-66Gy/ 24 fractions, inhomogeneous dose distribution proton therapy

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Tine Schytte, PhD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-09-30
Completion
2029-09-30

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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 NCT05548504 on ClinicalTrials.gov