Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country68 target enrollmentJanuary 5, 2021

ConditionsLung Cancer Metastatic

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lung Cancer Metastatic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment: 68
Locations: 1
Primary Endpoint: OS
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Registry

clinicaltrials.gov

Start Date

January 5, 2021

End Date

July 1, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years
•Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry
•Ability to provide written informed consent
•Eastern Cooperative Oncology Group (ECOG) performance status 0-3
•Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
•Oligoprogression while on ICI or TKI (any line)
•Patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care
•All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
•Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.

Exclusion Criteria

•Any lesion beyond 5 cm
•Pregnancy or breastfeeding
•Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
•Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)

Outcomes

Primary Outcomes

Time Frame: 5 years

OS defined as time from randomization to time of death from any cause.

PFS

Time Frame: 5 years

PFS defined from randomization to disease progression at any site or death

Secondary Outcomes

Time to next systemic therapy(5 years)
Quality of life 5-level EQ-5D (EQ-5D-5L)(5 years)
Local control(5 years)
Grade ≥ 3 toxicity(5 years)
Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE)(5 years)