Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-03-01 @ 3:21 PM
Study NCT ID:
NCT04128332
Status:
UNKNOWN
Last Update Posted:
2021-02-09
First Post:
2019-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days.', 'timeFrame': 'Up to 30days post surgery', 'description': 'Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery'}], 'secondaryOutcomes': [{'measure': 'Measure of surgical resection margin status following pre-operative SABR and immediate surgery', 'timeFrame': 'Post surgery', 'description': 'Measure of Resection margin status (R0 complete resection, R1 microscopic residual tumour, R2 macroscopic residual tumour) from the post surgery histopathology report'}, {'measure': 'Measure of local control post SABR and surgery', 'timeFrame': '1 year', 'description': 'Number of patients with local control from CT scans up to 12months from the start of SABR'}, {'measure': 'Measure of disease-free survival post SABR and surgery', 'timeFrame': '1 year', 'description': 'Number of patients with disease progression from CT scans up to 12months from the start of SABR'}, {'measure': 'Measure of overall survival post SABR and surgery', 'timeFrame': '1 year', 'description': 'Number of deaths up to 12 months from the start of SABR treatment'}, {'measure': 'Acute and late toxicity of pre-operative SABR: Number of adverse events', 'timeFrame': '1 year', 'description': 'Number of adverse events reported up to 12 months from the start of SABR treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer of Pancreas']}, 'descriptionModule': {'briefSummary': 'A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.', 'detailedDescription': "This is a single-centre, prospective, non-randomised feasibility study. This study will assess whether SABR can safely be given immediately prior to Whipple's resection by assessing the rate of post-operative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria Stage 1:\n\n* Have given written informed consent to participate in stage 1\n* Be aged 16 years or over at the time of signing the informed consent form\n* Presence of a hypodense pancreatic mass on contrast enhanced CT scan highly suspicious of operable primary pancreatic cancer as assessed by a pancreatic multi-disciplinary team (MDT)\n* Have not had pre-operative systemic therapy or radiotherapy\n\nInclusion Criteria Stage 2:\n\n* Have participated in stage 1 of the study\n* Have confirmed histological or cytological diagnosis of primary pancreatic adenocarcinoma OR radiological evidence of pancreatic head mass with supportive cytological or histological findings.\n* Be scheduled to undergo pancreatico-duodenectomy (Whipple's) resection.\n* Written informed consent to participate in stage 2\n* Aged 16 years or over at the time of signing informed consent\n* Have not had pre-operative systemic therapy or radiotherapy\n* ECOG Performance status 0-1\n* Adequate renal function: GFR ≥ 60\n\nExclusion Criteria:\n\n* Any condition or abnormalities that in the judgement of the investigator/surgeon/clinical oncologist would place the patient at undue risk\n* Women who are known to be pregnant\n* Previous abdominal radiotherapy\n* Women of child-bearing potential who are unwilling to use 2 highly effective forms of contraception during the study treatment period"}, 'identificationModule': {'nctId': 'NCT04128332', 'acronym': 'PORTICO-SABR', 'briefTitle': 'Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Cambridge University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study', 'orgStudyIdInfo': {'id': 'PORTICO-SABR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Stereotactic ablative radiotherapy (SABR)', 'description': 'Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days.', 'interventionNames': ['Radiation: Pre-operative stereotactic ablative body radiotherapy']}], 'interventions': [{'name': 'Pre-operative stereotactic ablative body radiotherapy', 'type': 'RADIATION', 'description': 'Stereotactic ablative body radiotherapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumour, while limiting the dose to the surrounding tissues.', 'armGroupLabels': ['Stereotactic ablative radiotherapy (SABR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Cb2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Addenbrookes Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'overallOfficials': [{'name': 'Thankamma Ajithkumar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge University Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CCTU- Cancer Theme', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr Thankamma Ajithkumar, Consultant Clinical Oncologist', 'investigatorFullName': 'CCTU- Cancer Theme', 'investigatorAffiliation': 'Cambridge University Hospitals NHS Foundation Trust'}}}}