Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-13 @ 11:48 AM
Study NCT ID:
NCT04081168
Status:
UNKNOWN
Last Update Posted:
2022-12-20
First Post:
2019-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COLLISION XL: Unresectable Colorectal Liver Metastases (3-5cm): Stereotactic Body Radiotherapy vs. Microwave Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stereotactic Body Radiotherapy vs. Microwave Ablation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-18', 'studyFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2019-09-04', 'lastUpdatePostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One-year local tumor progression-free survival', 'timeFrame': '1 year', 'description': 'One-year local tumor progression-free survival'}], 'secondaryOutcomes': [{'measure': 'Timo-to-local tumor progression', 'timeFrame': '5 years', 'description': 'Timo-to-local tumor progression'}, {'measure': 'Overall survival (OS)', 'timeFrame': '5 years', 'description': 'Overall survival (OS)'}, {'measure': 'Disease-Free Survival (DFS)', 'timeFrame': '5 years', 'description': 'Disease-Free Survival (DFS)'}, {'measure': 'Mortality', 'timeFrame': '5 years', 'description': 'Mortality'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer Metastatic', 'Liver Metastasis Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '37430016', 'type': 'DERIVED', 'citation': 'van der Lei S, Dijkstra M, Nieuwenhuizen S, Schulz HH, Vos DJW, Versteeg KS, Buffart TE, Swijnenburg RJ, de Vries JJJ, Bruynzeel AME, van den Tol MP, Scheffer HJ, Puijk RS, Haasbeek CJA, Meijerink MR; and COLLISION Trial Group. Unresectable Intermediate-Size (3-5 cm) Colorectal Liver Metastases: Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2023 Aug;46(8):1076-1085. doi: 10.1007/s00270-023-03498-8. Epub 2023 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'Multiple articles report that thermal ablation is a safe and effective treatment for unresectable colorectal liver metastases (CRLM) ≤3cm. However efficacy of thermal ablation decreases with increasing lesion size. Guidelines state that thermal ablation is the preferred option for unresectable CRLM ≤3cm and stereotactic body radiotherapy (SBRT) when thermal ablation is not possible. It remains uncertain what local treatment method should be recommended for unresectable CRLM of 3-5cm.', 'detailedDescription': 'Objective: The primary objective of this study is to compare efficacy of MWA to the efficacy of SBRT with regards to the primary endpoint (local tumour progression free survival at 1 year \\[1-year LTPFS\\]) in patients with unresectable CRLM (3 - 5 cm) that are unsuitable for surgery due to either comorbidities, a history of extensive abdominal surgery, a poor performance status or due to a certain unfavourable anatomical location of the tumour.\n\nStudy design: COLLISION XL is a prospective multi-centre phase-II randomized controlled trial.\n\nStudy population: 68 patients with 1-3 unresectable lesions of 3 - 5cm, unsuitable for (further) chemotherapy regimens, suitable for both MWA and SBRT and no or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis) are considered eligible. Supplementary resections for resectable lesions and thermal ablations for unresectable CRLM ≤3cm are allowed. A maximum number of 10 CRLM are allowed for patients with no extrahepatic disease and a maximum number of 5 lesions are allowed for patients with limited extrahepatic disease.\n\nIntervention: SBRT or MWA. The panel, consisting of at least two interventional radiologists, two hepatobiliary surgeons and two radiation oncologists, will appoint lesions of 3-5cm that are unresectable and suitable for both MWA and SBRT, as target lesions. All lesions that are not suitable for ablation should be resectable and all unresectable lesions \\<3cm should be suitable for thermal ablation.\n\nMain study parameters/endpoints: Primary endpoint is local tumour progression free survival (LTPFS) at 1 year from randomization. Secondary endpoints are local tumour progression free survival time, OS, disease-free survival (DFS), time to progression (TTP), procedural morbidity/toxicity and mortality, assessment of pain and quality of life (QoL) and cost-effectiveness ratio (ICER).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target lesions);\n* Additional CRLM are allowed if considered either resectable or ablatable and \\<3cm\n* No or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis);\n* For subjects with liver only disease the maximum number of CRLM is 10; for subjects with limited extrahepatic disease the maximum number of CRLM is 5;\n* Prior focal liver treatment is allowed\n* Subjects without prior focal liver treatment should be either unsuitable for 1st line chemotherapy or have progressed under/after 1st-line chemotherapy;\n* Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment should be unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable).\n\nExclusion Criteria:\n\n* Compromised liver function (e.g. signs of portal hypertension, INR \\> 1,5 without use of anticoagulants, ascites);\n* Pregnant or breast-feeding subjects;\n* Immunotherapy ≤ 6 weeks prior to the procedure;\n* Chemotherapy ≤ 6 weeks prior to the procedure;\n* Severe allergy to contrast media not controlled with premedication.'}, 'identificationModule': {'nctId': 'NCT04081168', 'acronym': 'COLLISION-XL', 'briefTitle': 'COLLISION XL: Unresectable Colorectal Liver Metastases (3-5cm): Stereotactic Body Radiotherapy vs. Microwave Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'COLLISION XL: Unresectable Colorectal Liver Metastases: Stereotactic Body Radiotherapy vs. Microwave Ablation - a Phase II Prospective Randomized Controlled Trial for Intermediate-size (3 - 5 cm) Colorectal Liver Metastases', 'orgStudyIdInfo': {'id': 'NL68326.029.19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stereotactic Body Radiotherapy', 'description': 'Patients included will undergo Stereotactic Body Radiotherapy (SBRT) of hepatic metastases.', 'interventionNames': ['Device: Stereotactic Body Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Microwave Ablation', 'description': 'Patients included will undergo Microwave Ablation (MWA) of hepatic metastases.', 'interventionNames': ['Device: Microwave Ablation']}], 'interventions': [{'name': 'Stereotactic Body Radiotherapy', 'type': 'DEVICE', 'otherNames': ['SBRT'], 'description': 'Patients will undergo Stereotactic Body Radiotherapy (SBRT)', 'armGroupLabels': ['Stereotactic Body Radiotherapy']}, {'name': 'Microwave Ablation', 'type': 'DEVICE', 'otherNames': ['MWA'], 'description': 'Patients will undergo Microwave Ablation (MWA)', 'armGroupLabels': ['Microwave Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081 HV', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Martijn Meijerink, MD, PhD', 'role': 'CONTACT', 'email': 'mr.meijerink@amsterdamumc.nl', 'phone': '+31204443047'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'S. van der Lei, MD', 'role': 'CONTACT', 'email': 's.vanderlei@amsterdamumc.nl', 'phone': '+31204443047'}, {'name': 'M.R. Meijerink, MD, PhD', 'role': 'CONTACT', 'email': 'mr.meijerink@amsterdamumc.nl', 'phone': '+31204443047'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. M.R. Meijerink', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}