Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)
NCT ID: NCT02756793
Last Updated: 2025-12-31
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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ACTIVE_NOT_RECRUITING
NA
90 participants
INTERVENTIONAL
2016-10-31
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care Treatment
Patient treatment may include the following 3 options, at the discretion of the treating physicians:
* Continue with current systemic agent(s)
* Observation
* Switch to next-line treatment
Standard of Care Treatment
May include:
* Continue with current systemic agent(s)
* Observation
* Switch to next-line treatment
Palliative radiotherapy is allowed in this arm.
Stereotactic Ablative Radiotherapy (SABR)
SABR is delivered to all sites of progressive disease with continuation of current systemic agents. Further oligo-progressive lesions may be treated with SABR if possible. Upon progression at sites not amenable to SABR, the patient may receive any of the options in Arm 1.
Stereotactic Ablative Radiotherapy (SABR)
Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.
Interventions
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Stereotactic Ablative Radiotherapy (SABR)
Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.
Standard of Care Treatment
May include:
* Continue with current systemic agent(s)
* Observation
* Switch to next-line treatment
Palliative radiotherapy is allowed in this arm.
Eligibility Criteria
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Inclusion Criteria
* 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
Note for Patients with Brain Metastases: For patients with brain metastases and oligo-progression elsewhere where stereotactic radiation to the brain is deemed to be warranted, this must be specified prior to randomization. If randomized to Standard Arm, patient would receive stereotactic radiation to brain only. If randomized to Experimental Arm, patient would receive stereotactic radiation to brain and to body lesions
Exclusion Criteria
* Prior radiotherapy to a site requiring treatment
* Malignant pleural effusion
* Inability to treat all sites of enlarging, oligoprogressive disease
* Clinical or radiological evidence of spinal cord compression or tumor within 3mm of spinal cord on MRI
* Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study
18 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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David Palma
Principal Investigator
Locations
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Alberta Health Services-Cross Cancer Institute
Edmonton, Alberta, Canada
BC Cancer - Prince George
Prince George, British Columbia, Canada
BC Cancer Fraser Valley Centre
Surrey, British Columbia, Canada
BC Cancer Agency Branch
Vancouver, British Columbia, Canada
BC Cancer - Victoria Centre
Victoria, British Columbia, Canada
London Regional Cancer Program
London, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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References
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Schellenberg D, Gabos Z, Duimering A, Debenham B, Fairchild A, Huang F, Rowe LS, Severin D, Giuliani ME, Bezjak A, Lok BH, Raman S, Chung P, Zhao Y, Ho CK, Lock M, Louie AV, Lefresne S, Carolan H, Liu M, Yau V, Ye A, Olson RA, Mou B, Mohamed IG, Petrik DW, Dosani M, Pai H, Valev B, Gaede S, Warner A, Palma DA. Stereotactic Ablative Radiation for Oligoprogressive Cancers: Results of the Randomized Phase 2 STOP Trial. Int J Radiat Oncol Biol Phys. 2025 Jan 1;121(1):28-38. doi: 10.1016/j.ijrobp.2024.08.031. Epub 2024 Aug 19.
Lee J, Koom WS, Byun HK, Yang G, Kim MS, Park EJ, Ahn JB, Beom SH, Kim HS, Shin SJ, Kim K, Chang JS. Metastasis-Directed Radiotherapy for Oligoprogressive or Oligopersistent Metastatic Colorectal Cancer. Clin Colorectal Cancer. 2022 Jun;21(2):e78-e86. doi: 10.1016/j.clcc.2021.10.009. Epub 2021 Nov 18.
Other Identifiers
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STOP
Identifier Type: -
Identifier Source: org_study_id