Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial) (NCT02756793) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)
Canada90 participantsStarted 2016-10
Plain-language summary
A multicenter randomized phase II trial of stereotactic body radiotherapy for oligo-progressive metastatic cancers. Eligible patients will be randomized in a 1:2 ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy (SABR) to all sites of oligo-progressive lesions.Radiotherapy will be administered as soon as possible following randomization, and subjects will be followed until next disease progression. The primary outcome is progression-free survival (PFS).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age 18 or older
* Willing to provide informed consent
* Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) with metastatic disease detected on imaging. Biopsy of metastasis at some time point prior to enrollment is preferred, but not required.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy \> 3 months
* Patient has received treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies) during the past 6 weeks. This most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (PR), complete response (CR) or stable disease (CR) prior to the development of oligo-progressive lesions.
* Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST)-documented progression in up to 5 individual lesions, with no previous radiation or radiofrequency ablation to those sites. Oligoprogression may be defined as:
* Progression of an individual metastasis according to RECIST 1.1 criteria
* Unambiguous development of a new metastatic lesion at least 5mm in size
* Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2- 3 months apart with a minimum 5mm increase in size from baseline
* All sites of oligoprogression can be safely treated
* Maximum 3 progressing metastases in any single organ system (i.e. lung, liver, brain, bone), and the total number of metastases must be 5 or less…
What they're measuring
1
Progression-Free Survival
Timeframe: 5 years
Trial details
NCT IDNCT02756793
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's