Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT06604533
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of local control (Local Response Rate).', 'timeFrame': 'Clinical progress imaging every 3 months post radiotherapy treatment until 3 years post radiotherapy.', 'description': 'To determine if patients treated with MRI guided stereotactic radiotherapy improves local control. Local control is defined as absence of progression in treated lesion(s) and will be measured via clinical progress imaging (and assessed using RECIST criteria).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abdominal Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of MRI-guided adaptive stereotactic radiotherapy on local control, survival, and toxicity in the treatment of oligometastatic cancer to the abdomen.', 'detailedDescription': 'This is an Australian-led multi-centre Phase 2 randomised controlled trial. The aim of this study is to investigate the effect of MRI-guided adaptive stereotactic radiotherapy on LC, survival, and toxicity in the treatment of oligometastatic cancer to the abdomen.\n\nThis study will provide one of the first high level phase 2 randomised evidence required to demonstrate this new technology improves patient clinical outcomes and inform the selection of patients for MRI-Linac treatment.\n\nThe primary objective is to evaluate the effect of MRI-guided adaptive stereotactic radiotherapy on 2 year LC of treated lesion(s) in patients with abdominal oligometastatic or primary liver cancer.\n\nAim 1: Quantify the effect of MRI-guided stereotactic radiotherapy on patient outcomes. Patient outcomes will be determined by measuring LC, survival, and safety (toxicity).\n\nAim 2: Quantify patient dose and cancer targeting accuracy. The ability of MRI-Linacs to treat more patients to a higher dose than standard linacs through adaptive dose-escalation and improved target coverage will be quantified. The delivered dose for each treatment arm will be compared.\n\nAim 3: Explore functional MRI biomarkers of radiotherapy response prediction. Candidate functional biomarkers of tumour perfusion and diffusion will be identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Patients with diagnosis of oligometastatic disease from primary colorectal, upper gastrointestinal (e.g. gastric, oesophagus, pancreatic), breast, non-small cell lung, renal cell, or gynaecological malignancy. Oligometastatic disease with controlled primary disease\\* and maximum total of 5 metastatic lesions in a maximum of 2 different organ systems in any of the following sites:\n\n 1. Liver\n 2. Adrenal\n 3. Abdomino-pelvic lymph node\n 4. Other abdominal site e.g. pancreatic, renal.\n 5. Other pelvic site\n 6. Bony or lung is allowed only if in conjunction with an abdominal site above\n* De novo or metachronous oligometastatic disease where the original tumour site has been treated with curative intent.\n\n * Controlled primary disease in metachronous oligometastastic disease defined as at least 3 months since original tumour treated with curative intent and no progression at primary site\n * Controlled primary disease in de novo oligometastatic disease defined as primary tumour site treated with curative intent and no progression at primary site\n* Oligometastatic disease: Histological confirmation of primary malignancy (histological confirmation of metastasis is not mandatory but should be performed in any situation where there is any diagnostic uncertainty).\n* All oligometastatic sites treatable with SABR.\n\nOR\n\n* Patients with oligo-progressive / oligo-persistent disease in maximum total of 2 oligo-progressive abdominal metastases and in a maximum 2 different organ systems\n* Visible imaging defined targets and suitable for treatment with SABR\n* Childs Pugh A to B7 (in case of liver treatment)\n* ECOG 0 -2\n* Patient consented\n\nExclusion Criteria:\n\n* Contra-indication to MRI\n* Previous high dose radiotherapy to a site requiring stereotactic treatment (including SIRTEX). Further SABR treatment of lesions previously treated with SABR or high dose radiotherapy is not permitted in this trial.\n* Substantial overlap with a previously treated high dose (definitive or stereotactic dose) radiation volume.\n* Primary prostate cancer, carcinoid tumours, germ cell tumours, lymphoma, small cell tumours\n* Pregnant women\n* Complete response of metastatic disease to systemic therapy (i.e. no target for SABR)\n* Competing medical co-morbidity with a more limited prognosis than the cancer diagnosis'}, 'identificationModule': {'nctId': 'NCT06604533', 'briefTitle': 'Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Australasian Gastro-Intestinal Trials Group'}, 'officialTitle': 'A Randomized Phase II Trial - Magnetic Resonance Imaging (MRI) Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer', 'orgStudyIdInfo': {'id': 'MR-STAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention: MRI-Linac SABR', 'description': 'The treatment planning protocol follows the UK SABR Consortium Guidelines. Patients will be prescribed the maximum isotoxic dose achievable while meeting normal organ tolerances (normal liver, kidney, spinal cord, stomach, duodenum, small and large bowel, heart, lungs, chest wall). The lowest acceptable SABR doses are indicated in the dose range Table within the protocol. The maximum dose/fraction also indicates the maximum the dose can be escalated to for each adaptive session on the MRI-Linac.', 'interventionNames': ['Procedure: Intervention: MRI-Linac SABR']}, {'type': 'NO_INTERVENTION', 'label': 'Control: Standard SABR', 'description': 'The treatment planning protocol follows the UK SABR Consortium Guidelines. Patients will be prescribed the maximum isotoxic dose achievable while meeting normal organ tolerances (normal liver, kidney, spinal cord, stomach, duodenum, small and large bowel, heart, lungs, chest wall). The lowest acceptable SABR doses are indicated in the dose range Table within the protocol. The maximum dose/fraction also indicates the maximum the dose can be escalated to for each adaptive session on the MRI-Linac.'}], 'interventions': [{'name': 'Intervention: MRI-Linac SABR', 'type': 'PROCEDURE', 'description': 'The treatment planning protocol follows the UK SABR Consortium Guidelines. Patients will be prescribed the maximum isotoxic dose achievable while meeting normal organ tolerances (normal liver, kidney, spinal cord, stomach, duodenum, small and large bowel, heart, lungs, chest wall). The lowest acceptable SABR doses are indicated in the dose range Table within the protocol. The maximum dose/fraction also indicates the maximum the dose can be escalated to for each adaptive session on the MRI-Linac.', 'armGroupLabels': ['Intervention: MRI-Linac SABR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jeremiah De Leon', 'role': 'CONTACT', 'email': 'jeremy.deleon@genesiscare.com', 'phone': '02 8302 5400'}, {'name': 'Jeremiah De Leon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "GenesisCare - St Vincent's Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3084', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sweet Ping Ng', 'role': 'CONTACT', 'email': 'SweetPing.NG@austin.org.au', 'phone': '0412 636 394'}, {'name': 'Sweet Ping Ng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Austin Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Sukanya Sathyamurthie', 'role': 'CONTACT', 'email': 'sukanya@gicancer.org.au', 'phone': '+61 2 7208 2719'}, {'name': 'Miriam Roesner', 'role': 'CONTACT', 'email': 'miriam@gicancer.org.au', 'phone': '+61 2 7208 2727'}], 'overallOfficials': [{'name': 'Trang Pham', 'role': 'STUDY_CHAIR', 'affiliation': 'South Western Sydney LHD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Australasian Gastro-Intestinal Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Trans Tasman Radiation Oncology Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}