Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer
NCT ID: NCT04405401
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
68 participants
INTERVENTIONAL
2021-01-05
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard of care
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
SABR
SABR to all oligoprogressive lesions + continuation of current systemic therapy
Experimental SABR arm
Definitive SABR to oligoprogressive lesions + continue current systemic therapy
Standard of care
Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.
Interventions
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SABR
SABR to all oligoprogressive lesions + continuation of current systemic therapy
Standard of care
Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Houda Bahig, MD PhD
Role: STUDY_CHAIR
Centre hospitalier de l'Université de Montréal (CHUM)
Bertrand Routy, MD PhD
Role: STUDY_CHAIR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
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Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Diane Trudel
Role: primary
Other Identifiers
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2021-9066
Identifier Type: -
Identifier Source: org_study_id