Clinical trial · Interventional
Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)
Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial): A Randomized Phase II Trial
NCT02756793CI-TRIAL-00099952active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care Treatment | Other | — | UNRESOLVED |
| Stereotactic Ablative Radiotherapy (SABR) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Treatment
- description
- 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
- interventionNames
- Other: Standard of Care Treatment
- type
- EXPERIMENTAL
- label
- Stereotactic Ablative Radiotherapy (SABR)
- description
- 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.
- interventionNames
- Radiation: Stereotactic Ablative Radiotherapy (SABR)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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: * Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma. For patients with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease * 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
References
Publications (2)
- DERIVEDSchellenberg 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. PMID 39168356
- DERIVEDLee 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. PMID 34903471