Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-11 @ 3:14 PM
Study NCT ID:
NCT05862051
Status:
UNKNOWN
Last Update Posted:
2023-10-17
First Post:
2022-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-06-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-15', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '12 Months from randomisation', 'description': 'To compare the efficacy of metastasis-directed LAT following initial standard first-line systemic treatment vs continued first-line systemic treatment alone, as measured by Progression-Free Survival (PFS)'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '12 Months from randomisation and through study completion, an average of 1 year', 'description': 'To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, as measured by Overall Survival (OS)'}, {'measure': 'Efficacy of local ablative therapy', 'timeFrame': '12 Months from randomisation and through study completion, an average of 1 year', 'description': 'To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, on:\n\n1. time to development of new metastatic lesions.\n2. time to initiation of 2nd line systemic treatment.'}, {'measure': 'Time to progression following local ablative therapy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'To assess the time to progression of LAT treated lesions.'}, {'measure': 'Systemic treatment-free interval', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'To compare systemic treatment-free interval between the two treatment groups.'}, {'measure': 'Rate of high-grade toxicities', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'To assess and compare rate of high-grade (Grade 3-5) toxicities between the two treatment groups.'}, {'measure': 'Quality of life measure', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'To compare quality of life measures between the two treatment groups using patient questionnaire - The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) using the 4-point ordinal scale (not at all, a little, quite a bit and very much)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Oligometastatic Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment including the impact on survival, compared to continued standard first-line systemic treatment for oligometastatic colorectal cancer.', 'detailedDescription': 'Who is this study for:\n\nAdults with unresectable oligo-metastatic colorectal who have demonstrated treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.\n\nStudy details\n\nParticipants will be randomly allocated to either a LAT arm, who will receive metastasis-directed LAT such as radiotherapy or thermal ablation following initial standard first-line systemic treatment, or a control arm who will receive continued first-line systemic treatment alone. Those receiving LAT will return to systemic treatment 16 weeks post-randomisation. Information on progression-free survival and treatment outcomes will be collected.\n\nData from this study will inform investigators of the potential benefit of local ablative therapy in the therapeutic setting for metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Metastatic colorectal adenocarcinoma that is not amenable to potentially oncological curative surgery alone.\n* Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry\n* Imaging demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.\n* At least one metastatic lesion detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screening FDG-PET and CT scans, meeting the following criteria:\n\n 1. max of 3 lesions per organ except for the liver and lung\n 2. max of 5 lesions in the lung\n 3. no limitation to the number of liver lesions provided they are all amenable to LAT\n 4. max of 3 involved organs including a lymph node station\n 5. only one lymph node station involvement is allowed\n 6. for patients with liver metastases, a quadruple phase contrast enhanced CT or MRI liver is required to fully stage the liver; this can be performed prior to or within 4 weeks of commencing first line systemic treatment\n 7. staging FDG-PET scan is encouraged and can be performed prior to or within 4 weeks of commencing first line systemic treatment\n* All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.\n\nExclusion Criteria:\n\n* Deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-high) tumour\n* BRAFV600E mutated tumour\n* Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease or prostate cancer with a Gleason score ≤6.\n* Presence of brain, peritoneal, omental or ovarian metastases\n* Malignant pleural effusion or ascites."}, 'identificationModule': {'nctId': 'NCT05862051', 'acronym': 'RESOLUTE', 'briefTitle': 'RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Australasian Gastro-Intestinal Trials Group'}, 'officialTitle': 'Randomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy With First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'RESOLUTE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Local ablative therapies (LAT) arm', 'description': 'A maximum of three Local ablative therapy (LAT) modalities can be administered for each participant, with a maximum of 2 modalities per organ, provided all LAT can be delivered within 12 weeks and participant can safely resume systemic treatment within 16 weeks from randomisation.\n\nAfter completing LAT, participant is to resume a further two to three months of first-line systemic treatment to a total of 6 months (including the initial 3-4 months of treatment). For patients receiving a doublet or triplet regimen, treatment may be de-escalated to maintenance fluoropyrimidine +/- biologics or anti-EGFR monotherapy at any point after trial entry at clinician discretion. The treating clinician may choose to discontinue systemic treatment following LAT for patients who have experienced prior intolerable toxicity.', 'interventionNames': ['Procedure: Local Ablative Therapy', 'Procedure: Standard first-line systemic treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'The first-line systemic treatment will be standard of care as determined by the treating clinician. The following standard chemotherapy regimens are allowed: single agent fluoropyrimidine, CAPOX, FOLFOX, FOLFIRI, CAPIRI or FOLFOXIRI. Treatment with a biologic is allowed including bevacizumab or an anti-EGFR antibody (cetuximab or panitumumab). For patients receiving a doublet or triplet regimen, treatment may be de-escalated to maintenance fluoropyrimidine +/- biologics or anti-EGFR monotherapy at any point after trial entry at clinician discretion.', 'interventionNames': ['Procedure: Standard first-line systemic treatment']}], 'interventions': [{'name': 'Local Ablative Therapy', 'type': 'PROCEDURE', 'description': 'LAT modalities allowed include surgical resection, stereotactic radiotherapy (SRT), laparoscopic or percutaneous thermal ablation \\[radiofrequency ablation (RFA) or microwave ablation (MWA)\\]. The LAT modalities will be delivered by specialists in the field (surgeons, radiation oncologists and/or interventional radiologists). The precise mode of delivery and number of times the LAT modality is delivered is case-dependent and is determined at a multi-disciplinary meeting (MDM).', 'armGroupLabels': ['Local ablative therapies (LAT) arm']}, {'name': 'Standard first-line systemic treatment', 'type': 'PROCEDURE', 'description': 'Standard of care as determined by the treating clinician. The following standard chemotherapy regimens are allowed: single agent fluoropyrimidine, CAPOX, FOLFOX, FOLFIRI, CAPIRI or FOLFOXIRI. Treatment with a biologic is allowed including bevacizumab or an anti-EGFR antibody (cetuximab or panitumumab). For patients receiving a doublet or triplet regimen, treatment may be de-escalated to maintenance fluoropyrimidine +/- biologics or anti-EGFR monotherapy at any point after trial entry at clinician discretion.', 'armGroupLabels': ['Control arm', 'Local ablative therapies (LAT) arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2640', 'city': 'Albury', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jacqui Mcburnie', 'role': 'CONTACT', 'email': 'Jacqui.Mcburnie@bordermedonc.com.au'}], 'facility': 'Border Medical Oncology', 'geoPoint': {'lat': -36.07482, 'lon': 146.92401}}, {'zip': '3550', 'city': 'Bendigo', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Narelle McPhee', 'role': 'CONTACT', 'email': 'NMcPhee@bendigohealth.org.au'}], 'facility': 'Bendigo Hospital', 'geoPoint': {'lat': -36.75818, 'lon': 144.28024}}, {'zip': '3128', 'city': 'Box Hill', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Rachel Wong', 'role': 'CONTACT', 'email': 'Rachel.Wong@monash.edu'}], 'facility': 'Eastern Health', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '3076', 'city': 'Epping', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Karen Matoga', 'role': 'CONTACT', 'email': 'Karen.Matoga2@nh.org.au'}], 'facility': 'The Northern Hospital', 'geoPoint': {'lat': -37.65, 'lon': 145.03333}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Nadia Ranieri', 'role': 'CONTACT', 'email': 'Nadia.ranieri@svha.org.au'}], 'facility': "St Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Marie Luci', 'role': 'CONTACT', 'email': 'marie.luci@ctaust.org'}, {'name': 'Jeanne Tie', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peter MaCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3940', 'city': 'Rosebud', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sally Heath', 'role': 'CONTACT', 'email': 'sallyheath@phcn.vic.gov.au'}], 'facility': 'Peninsula Health', 'geoPoint': {'lat': -38.35542, 'lon': 144.9068}}, {'zip': '3021', 'city': 'Saint Albans', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Stephanie Henderson', 'role': 'CONTACT', 'email': 'Stephanie.Henderson@ctaust.org'}], 'facility': 'Western Health', 'geoPoint': {'lat': -37.73333, 'lon': 144.8}}, {'zip': '3677', 'city': 'Wangaratta', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Nicole Humphreys', 'role': 'CONTACT', 'email': 'Nicole.Humphreys@nhw.org.au'}], 'facility': 'Northeast Health Wangaratta', 'geoPoint': {'lat': -36.35846, 'lon': 146.32056}}], 'centralContacts': [{'name': 'Sukanya Sathyamurthie', 'role': 'CONTACT', 'email': 'sukanya@gicancer.org.au', 'phone': '+61 2 7208 2719'}, {'name': 'Louise Christophersen', 'role': 'CONTACT', 'email': 'louise@gicancer.org.au', 'phone': '+61 2 7208 2718'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Australasian Gastro-Intestinal Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Walter and Eliza Hall Institute of Medical Research', 'class': 'OTHER'}, {'name': 'Cancer Council Victoria', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}