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Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC

ConditionsNon Small Cell Lung CancerStage III Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

This study investigates whether postoperative radiotherapy (PORT) improves outcomes for patients with stage III non-small cell lung cancer (NSCLC) who have residual disease after neoadjuvant chemo-immunotherapy and surgery. The primary objective is to compare event-free survival (EFS) between patients receiving PORT targeting involved lymph node regions and those without PORT. Secondary and tertiary endpoints include overall survival, locoregional and distant control, toxicity, and quality of life. The phase II randomized trial will enroll 118 patients, stratifying by adjuvant immunotherapy use, with follow-up extending up to 5 years. Statistical analysis aims to detect a 15% improvement in 2-year EFS, with a total study duration of 7 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be ≥ 18 years old

Ability to provide written informed consent

ECOG performance status 0-2

Histologically confirmed NSCLC

Disqualifiers

Pregnant individuals

Previous chest radiotherapy

>24 weeks after thoracic surgery

History of other non-cutaneous neoplasms within the last 24 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Post-operative radiotherapy

    Radiation

    Mediastinal post-operative radiotherapy to a dose of 40 Gy in 15 fractions

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Post-operative radiotherapyExperimental treatment 1 intervention
Group B: No post-operative radiotherapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Disease-free Survival

Time frame
Defined as the time from random assignment to loco-regional or distant recurrence, or death from any cause, assessed up to 60 months.

Secondary outcomes

1

Overall Survival

Time frame
Time from random assignment to death from any cause, assessed up to 60 months.
2

Grade 3 Toxicity

Time frame
Classified as early (within the first 3 months) or late (after 3 months), assessed up to 60 months.
3

Locoregional control

Time frame
Time from random assignment to locoregional recurrence, proven radiologically and/or pathologically, assessed up to 60 months.
4

Distant metastasis free survival

Time frame
Time from random assignment to distant recurrence, proven radiologically and/or pathologically, or death from any cause, assessed up to 60 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Source ClinicalTrials.gov
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