Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-18 @ 4:32 AM
Study NCT ID:
NCT03648632
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2018-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resection rate for all patients starting SBRT', 'timeFrame': '12 month', 'description': 'Resection rate for all patients starting SBRT'}], 'secondaryOutcomes': [{'measure': '1 year survival for all patients starting SBRT', 'timeFrame': '12 month', 'description': '1 year survival for all patients starting SBRT'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '12 month', 'description': 'PFS will be calculated from the date of registration to the date of documented progressive disease'}, {'measure': 'Overall survival (OS)', 'timeFrame': '12 month', 'description': 'OS will be calculated from the date of registration to the date of documented progressive disease'}, {'measure': 'Adverse events grade 2-5 (NCI-CTCAE 4.1)', 'timeFrame': '12 month', 'description': 'Adverse events grade 2-5 (NCI-CTCAE 4.1)'}, {'measure': 'Surgical complications, including irreversible electroporation (IRE) (Clavien-Dindo)', 'timeFrame': '30 days', 'description': 'Complication rate will be gathered.'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Mortality rate'}, {'measure': 'Mortality', 'timeFrame': '90 days', 'description': 'Mortality rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stereotactic Radiotherapy'], 'conditions': ['Locally Advanced Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '38815694', 'type': 'DERIVED', 'citation': 'Weisz Ejlsmark M, Bahij R, Schytte T, Ronn Hansen C, Bertelsen A, Mahmood F, Bau Mortensen M, Detlefsen S, Weber B, Bernchou U, Pfeiffer P. Adaptive MRI-guided stereotactic body radiation therapy for locally advanced pancreatic cancer - A phase II study. Radiother Oncol. 2024 Aug;197:110347. doi: 10.1016/j.radonc.2024.110347. Epub 2024 May 28.'}]}, 'descriptionModule': {'briefSummary': 'Stereotactic Radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (LAPC).\n\nA Danish phase II study.', 'detailedDescription': "Combination chemotherapy (e.g. FOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin), Gem-Abraxane, Gem-Cap, Gem-S1) is standard of care in patients with LAPC but more and more scientific studies point to the fact that patients without sign of progressive disease (PD) will benefit from additional radiotherapy and especially SBRT.\n\nThe sample size is based on Simon's two stages mini-max design. This design ensures early study termination if there is insufficient effect.\n\nA resection rate less than 10% after SBRT is not clinically acceptable. Assuming a significance level at 0.1 (α = 0.1) and a power at 90% (β = 0.10) it can be calculated, that 16 patients should be included in the first part of the study. The enrolment will continue until 16 patients have completed SBRT and have been re-evaluated for resection by CT scan (and endoscopic ultrasonography + laparoscopic ultrasound, if available). If 1 or less out of the first 16 consecutive patients are being resected the investigators will reject our hypotheses and close the study after the first stage of accrual. If 2 or more patients are resected, an additional 9 patients will be accrued in the second stage. If at least 4 out of 25 patients are resected, a true resection rate of 30% cannot be excluded, and the investigators will conclude that the treatment is effective enough to continue with future studies.\n\nTo ensure 25 evaluable patients the investigators will include a total of 30 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LAPC (Karolinska Type B, C or D1)\n* Cytologically or histologically verified adenocarcinoma/carcinoma\n* Prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease\n* The patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery)\n* World Health Organization performance status 0-1\n* Age ≥ 18 years\n* Adequate hepatic function: bilirubin \\<3.0 x Upper Normal Limit, International Normalized Ratio \\<1.6, Activated Partial Thromboplastin Time \\< 1,5 x Upper Normal Limit. Patients with obstruction of bile duct or gut must be drained before start of therapy\n* Oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration.\n\nExclusion Criteria:\n\n* M1 disease\n* Prior radiotherapy to abdominal cavity\n* Pregnancy or breast-feeding. Fertile patients must use adequate contraceptives\n* Severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)'}, 'identificationModule': {'nctId': 'NCT03648632', 'acronym': 'SBRT-PC-01', 'briefTitle': 'Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC)', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Stereotactic Radiotherapy (SBRT) in Patients With Locally Advanced Pancreatic Cancer (LAPC). A Danish Phase II Study', 'orgStudyIdInfo': {'id': 'KFE 18.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stereotactic Radiotherapy', 'description': '50 Gy in 5 fractions within a total of 7 - 8 days', 'interventionNames': ['Radiation: Stereotactic Radiotherapy']}], 'interventions': [{'name': 'Stereotactic Radiotherapy', 'type': 'RADIATION', 'description': 'Patients should be treated with 50 Gy in 5 fractions within a total of 7 - 8 days.', 'armGroupLabels': ['Stereotactic Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Per Pfeiffer, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense Universitetshospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Per Pfeiffer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Per Pfeiffer', 'investigatorAffiliation': 'Odense University Hospital'}}}}