Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT02756793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-03
First Post:
2016-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-30', 'studyFirstSubmitDate': '2016-04-28', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': '5 years', 'description': 'Progression-Free Survival is defined as the time from randomization to progression of disease or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'Overall survival is defined as they time from randomization to death from any cause'}, {'measure': 'Quality of Life', 'timeFrame': '5 years', 'description': 'Quality of life in domains of physical, social/family, emotional, and functional well-being will be assessed with the Functional Assessment of Cancer Therapy (FACT-G)'}, {'measure': 'Toxicity', 'timeFrame': '5 years', 'description': 'Toxicity related to radiation treatment will be assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 for each organ treated (i.e. liver, lung, bone)'}, {'measure': 'Lesional Control Rate', 'timeFrame': '5 years', 'description': 'Local control rate of lesions treated with SABR'}, {'measure': 'Total Time on Chemotherapy', 'timeFrame': '5 years', 'description': 'Duration of systemic therapy treatment'}, {'measure': 'Duration of current systemic agent treatment after SABR', 'timeFrame': '5 years', 'description': 'Arm 2 only'}, {'measure': 'Location of sites of further progression after SABR', 'timeFrame': '5 years', 'description': 'Sites of progressive disease after SABR are captured in follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Cancer']}, 'referencesModule': {'references': [{'pmid': '39168356', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34903471', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Willing to provide informed consent\n* 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.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Life expectancy \\> 3 months\n* 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.\n* 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:\n* Progression of an individual metastasis according to RECIST 1.1 criteria\n* Unambiguous development of a new metastatic lesion at least 5mm in size\n* Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2- 3 months apart with a minimum 5mm increase in size from baseline\n* All sites of oligoprogression can be safely treated\n* 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\n\nNote 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\n\nExclusion Criteria:\n\n* 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\n* Prior radiotherapy to a site requiring treatment\n* Malignant pleural effusion\n* Inability to treat all sites of enlarging, oligoprogressive disease\n* Clinical or radiological evidence of spinal cord compression or tumor within 3mm of spinal cord on MRI\n* Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study'}, 'identificationModule': {'nctId': 'NCT02756793', 'briefTitle': 'Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial): A Randomized Phase II Trial', 'orgStudyIdInfo': {'id': 'STOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Treatment', 'description': 'Patient treatment may include the following 3 options, at the discretion of the treating physicians:\n\n* Continue with current systemic agent(s)\n* Observation\n* 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)']}], 'interventions': [{'name': 'Stereotactic Ablative Radiotherapy (SABR)', 'type': 'RADIATION', 'description': 'Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.', 'armGroupLabels': ['Stereotactic Ablative Radiotherapy (SABR)']}, {'name': 'Standard of Care Treatment', 'type': 'OTHER', 'description': 'May include:\n\n* Continue with current systemic agent(s)\n* Observation\n* Switch to next-line treatment\n\nPalliative radiotherapy is allowed in this arm.', 'armGroupLabels': ['Standard of Care Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alberta Health Services-Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V2M 7E9', 'city': 'Prince George', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer - Prince George', 'geoPoint': {'lat': 53.9166, 'lon': -122.75301}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Fraser Valley Centre', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency Branch', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 4X1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer - Victoria Centre', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Regional Cancer Program', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G1X6', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Palma', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}