Description:
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.
Title
- Brief Title: Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer
- Official Title: Stereotactic Ablative Radiotherapy for Oligo-Progressive Disease REfractory to Systemic Therapy in Non Small Cell Lung Cancer: A Registry-based Phase II Randomized Trial
Clinical Trial IDs
- ORG STUDY ID:
PERaLung2.0
- NCT ID:
NCT04405401
Conditions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Standard of care | Active Comparator | Switch to subsequent systemic therapy line, best supportive care or continue current systemic line | |
Experimental SABR arm | Experimental | Definitive SABR to oligoprogressive lesions + continue current systemic therapy | |
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)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | PFS |
Time Frame: | 5 years |
Safety Issue: | |
Description: | PFS defined from randomization to disease progression at any site or death |
Secondary Outcome Measures
Measure: | Quality of life Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Measured using the FACT-G tool, lung cancer-related patient reported outcome- CTCAE (PRO-CTCAE) |
Measure: | Quality of life 5-level EQ-5D (EQ-5D-5L) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | questionnaire |
Measure: | Grade ≥ 3 toxicity |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) |
Measure: | Local control |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Defined as time from the end of SABR treatment to date of local failure and will be measured only in the experimental arm |
Measure: | Time to next systemic therapy |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Defined as time from randomization to time of subsequent therapy line |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Centre hospitalier de l'Université de Montréal (CHUM) |
Trial Keywords
- non small cell lung cancer
- oligoprogression
- steretactic body radiotherapy
Last Updated
February 21, 2021