Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT05428735
Status:
RECRUITING
Last Update Posted:
2024-11-01
First Post:
2022-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The DRAGON 2 Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}], 'ancestors': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 Randomization between control and interventional group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 348}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-06-17', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume sufficient for resection at week 3 after the embolization', 'timeFrame': '3 weeks', 'description': 'Volume sufficient for resection will be based on the first week or third week CT/MR Volumetry. Vauthey calculation for TLV will be used and the FLR volume will be measured centrally (objective panel)'}, {'measure': '5-year Overall Survival', 'timeFrame': '5 years', 'description': 'survival data will be recorded up to 5-years.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer Liver Metastases (CRLM)', 'Small Future Liver Remnant (FLR)']}, 'descriptionModule': {'briefSummary': 'In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).', 'detailedDescription': 'Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to chemotherapy alone and may lead to cure in up to 40% of patients. Extended liver resections are sometimes necessary to resect primarily unresectable/ potentially resectable (PU/PR) colorectal liver metastases. These resections are generally performed if the volume of the future liver remnant (FLR) comprises at least 30% of the total volume of the liver (without the volume of the metastases) or when liver function of the FLR on technetium-99m (99mTc) scintigraphy exceeds 2.67%/min/m2.\n\nWhen this liver volume or function criterion is not met, a high chance of post-hepatectomy liver failure exists. To prevent this, the induction of liver regeneration between a two-stage hepatectomy is commonly performed.\n\nThe current standard procedure to induce regeneration is the embolization of the portal vein branches to the tumor carrying liver (PVE) to induce hypertrophy of the remaining part of the liver which will serve as the FLR. Recently, combined embolization of both portal and hepatic veins (PVE/HVE) has been described as a possible superior alternative to PVE, as it increases and accelerates hypertrophy of the FLR. PVE/HVE combines simultaneous embolization of the main portal vein branches into the tumor carrying liver and the hepatic vein draining this part of the liver. Preclinical studies in pigs, several retrospective studies, and the prospective DRAGON 1 interim analysis (n=60) have demonstrated the safety and feasibility of this novel technique. However, no international randomized controlled trial has been performed, in which combined PVE/HVE is compared with PVE'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primarily unresectable/ potentially resectable CRLM with a FLR \\<30% (\\<40% in chemotherapy damaged livers)\n* Patients with non-resected primary CRC may be included if there is an intention to resect the CRC after the liver treatment (liver first approach) or simultaneously during one of the liver procedures.\n* Patients with resectable or ablatable lung or brain metastases can be included (statement about the resectability of these extrahepatic metastases by a tumor board needs to be available)\n* 18 Years and older\n* Men and women\n* Able to understand the trial and provide informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating female.\n* Premenopausal females not able or willing to commit to oral contraception\n* Patients with prohibitive comorbidities, decision made by local team\n* Any patient with non-resectable or non-ablatable extrahepatic disease\n* Patients with hepatic malignancies other than CRLM\n* Progression of disease by RECIST criteria after cytoreduction chemotherapy\n* Complete response after conversion chemotherapy\n* Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease\n* The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.'}, 'identificationModule': {'nctId': 'NCT05428735', 'acronym': 'DRAGON 2', 'briefTitle': 'The DRAGON 2 Trial', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)', 'orgStudyIdInfo': {'id': 'NL80303.068.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Portal Vein Embolization (PVE) alone - (control arm)', 'description': 'Portal Vein Embolization (PVE) alone', 'interventionNames': ['Procedure: Embolization']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)', 'description': 'Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)', 'interventionNames': ['Procedure: Embolization']}], 'interventions': [{'name': 'Embolization', 'type': 'PROCEDURE', 'description': 'Portal Vein embolization with Glue by a transhepatic approach vs. PVE and Hepatic Vein Occlusion with Vascular plugs via a transjugular or transfemoral approach in the same session as the PVE procedure', 'armGroupLabels': ['Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)', 'Portal Vein Embolization (PVE) alone - (control arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Billingsley', 'role': 'CONTACT'}, {'name': 'David Madoff', 'role': 'CONTACT'}], 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Diederick De Boo, PhD', 'role': 'CONTACT'}], 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '1100', 'city': 'Vienna', 'state': 'Vienna', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Thomas Gruenberger, MD', 'role': 'CONTACT'}, {'name': 'Tanja Friz, BSc', 'role': 'CONTACT'}, {'name': 'Tony Padickakudy', 'role': 'CONTACT'}, {'name': 'Tanja Fritz', 'role': 'CONTACT'}, {'name': 'Ivan Baclija', 'role': 'CONTACT'}], 'facility': 'Social Medical Center, South', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Brussels', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Valerio Lucidi, MD PhD', 'role': 'CONTACT'}, {'name': 'Viviane van Laethem', 'role': 'CONTACT'}, {'name': 'Illario Tancredi, MD PhD', 'role': 'CONTACT'}], 'facility': 'Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4000', 'city': 'Liège', 'state': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Celine Lambrecht', 'role': 'CONTACT'}, {'name': 'Olivier Detry', 'role': 'CONTACT'}, {'name': 'Olivier Detry, MD PhD', 'role': 'CONTACT'}, {'name': 'Laurent Gérard, MD PhD', 'role': 'CONTACT'}], 'facility': 'CHU de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5530', 'city': 'Yvoir', 'state': 'Namen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Aelxandra Dili, MD PhD', 'role': 'CONTACT'}, {'name': 'Claude Bertrand, MD PhD', 'role': 'CONTACT'}, {'name': 'Alexandra Dili, MD PhD', 'role': 'CONTACT'}, {'name': 'Jean- François De Wispelaere, MD PhD', 'role': 'CONTACT'}], 'facility': 'CHU-UCL Namur site Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': 'Gent (9000)', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Luis Luis Abreu de Carvalho', 'role': 'CONTACT'}, {'name': 'Luis Abreu de Carvalho', 'role': 'CONTACT'}, {'name': 'Laurens Hermie', 'role': 'CONTACT'}], 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'V5Z 4H5', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Maja Segedi', 'role': 'CONTACT'}, {'name': 'Maya Segedi', 'role': 'CONTACT'}], 'facility': 'Vancouver Coastal Health', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'ON L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Leyo Ruo', 'role': 'CONTACT'}], 'facility': 'Juravinski Hospital and Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'k1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Guillaume Martel, MD', 'role': 'CONTACT'}, {'name': 'Stephen Ryan, MD, PhD', 'role': 'CONTACT'}, {'name': 'Aklile Workneh', 'role': 'CONTACT'}], 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Karanicolas', 'role': 'CONTACT'}], 'facility': 'Sunnybrook Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jeniffer Kalil', 'role': 'CONTACT'}, {'name': 'Peter Metrakos, Prof', 'role': 'CONTACT'}, {'name': 'David Valenti, Md PhD', 'role': 'CONTACT'}], 'facility': 'McGill University Health Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Aldrighetti, Prof', 'role': 'CONTACT'}, {'name': 'Stephanie Steidler', 'role': 'CONTACT'}, {'name': 'Luca Aldrighetti, Prof.', 'role': 'CONTACT'}, {'name': 'Francesco De Cobelli, Prof.', 'role': 'CONTACT'}, {'name': 'Francesca Ratti, Dr.', 'role': 'CONTACT'}, {'name': 'Simone Gusmini, Dr.', 'role': 'CONTACT'}, {'name': 'Salvatore Lamarca, Dr.', 'role': 'CONTACT'}], 'facility': 'IRCCS San Raffaele Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Remon Korenblik, MD', 'role': 'CONTACT', 'email': 'remon.korenblik@mumc.nl', 'phone': '+31637297507'}, {'name': 'Ronald M van Dam, MD, PhD', 'role': 'CONTACT', 'email': 'r.van.dam@mumc.nl'}, {'name': 'Ronald M van Dam, MD, PhD', 'role': 'CONTACT'}, {'name': 'Marc HA Bemelmans, MD, PhD', 'role': 'CONTACT'}, {'name': 'Christiaan van der Leij, MD, PhD', 'role': 'CONTACT'}, {'name': 'Remon Korenblik, MD', 'role': 'CONTACT'}, {'name': 'Bram Olij, BCs', 'role': 'CONTACT'}], 'facility': 'Maastricht University Medical Center+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joris I Erdmann, MD PhD', 'role': 'CONTACT'}, {'name': 'Otto M van Delden, MD PhD', 'role': 'CONTACT'}], 'facility': 'Amsterdam UMC, location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713 GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marieke T de Boer, MD PhD', 'role': 'CONTACT'}, {'name': 'Jan T Bottema', 'role': 'CONTACT'}, {'name': 'Koert P de Jong', 'role': 'CONTACT'}, {'name': 'Reinhoud PH Bokkers', 'role': 'CONTACT'}, {'name': 'Leanne van der Plas - Kemper', 'role': 'CONTACT'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3015', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Dirk J. Grünhagen, MD PhD', 'role': 'CONTACT'}, {'name': 'Adriaan Moelker, MD PhD', 'role': 'CONTACT'}, {'name': 'Drik J Grünhagen, MD PhD', 'role': 'CONTACT'}], 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Breda', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Farshad Imani, MD PhD', 'role': 'CONTACT'}, {'name': 'Paul Gobardhan, MD PhD', 'role': 'CONTACT'}], 'facility': 'Amphia', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wouter Leclercq, MD PhD', 'role': 'CONTACT'}, {'name': 'Wouter KG Leqlercq, MD PhD', 'role': 'CONTACT'}, {'name': 'Laurens van Baardewijk, MD PhD', 'role': 'CONTACT'}], 'facility': 'Maxima Medisch Centrum', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Maarten LJ Smits, MD PhD', 'role': 'CONTACT'}, {'name': 'Jeroen Hagendoorn, MD PhD', 'role': 'CONTACT'}, {'name': 'Inne HM Borel Rinkes, Prof.', 'role': 'CONTACT'}, {'name': 'Rutger CG Bruijnen, MD PhD', 'role': 'CONTACT'}], 'facility': 'Universitair Medisch Centrum Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '581 85', 'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Per Sandström, Prof.', 'role': 'CONTACT'}, {'name': 'Bergthor Bjornsson, MD', 'role': 'CONTACT'}, {'name': 'Margareta Ahle, MD', 'role': 'CONTACT'}, {'name': 'Anna Lindhoff Larsson', 'role': 'CONTACT'}], 'facility': 'Linköping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '14186', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ernesto Sparrelid, MD', 'role': 'CONTACT'}, {'name': 'Martin Delle, MD', 'role': 'CONTACT'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': 'CH-4058', 'city': 'Basel', 'state': 'Canton of Basel-City', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Otto Kollmar, Prof.', 'role': 'CONTACT'}, {'name': 'Bettina Woelnerhanssen', 'role': 'CONTACT'}, {'name': 'Martin Hoffman, Prof.', 'role': 'CONTACT'}, {'name': 'Gabriel Hess, Dr.', 'role': 'CONTACT'}, {'name': 'Bettina Woelnershanssen', 'role': 'CONTACT'}], 'facility': 'Claraspital & Clarunis University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '8401', 'city': 'Winterthur', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Erik Schadde, MD', 'role': 'CONTACT'}, {'name': 'Sabine Kern', 'role': 'CONTACT'}, {'name': 'Chistoph A Binkert, MD', 'role': 'CONTACT'}], 'facility': 'Kantonsspital Winterthur (KSW)', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}], 'centralContacts': [{'name': 'Sinéad James, MD, PhD-candidate', 'role': 'CONTACT', 'email': 'sinead.james@mumc.nl', 'phone': '+31 638463945'}, {'name': 'Jens Smits', 'role': 'CONTACT', 'email': 'jens.smits@mumc.nl', 'phone': '+31640725518'}], 'overallOfficials': [{'name': 'Ronald M. van Dam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht Universitair Medisch Centrum'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'Upon reasonable request', 'accessCriteria': 'Proposal accepted by the DRAGON Collaborative Scientific Committee'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}