Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT02347618
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2014-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], '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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-15', 'size': 283794, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-05T17:16', 'hasProtocol': True}, {'date': '2017-11-16', 'size': 154742, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-07-06T16:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2014-12-24', 'studyFirstSubmitQcDate': '2015-01-21', 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of grade 2 or greater toxicity', 'timeFrame': '2 years', 'description': 'Number of incidence of grade 2 or greater toxicity'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with no further growth of cancer at original site (Local control)', 'timeFrame': '2 years', 'description': 'Count subjects with no further growth of cancer at original site.'}, {'measure': 'Count subjects with Recurrence of cancer in other body sites', 'timeFrame': '2 years', 'description': 'Compare recurrence locations of treated patients relative to historical controls.'}, {'measure': 'Time to Progression of pancreatic cancer', 'timeFrame': '4 years', 'description': 'Duration of progression free survival of treated patients'}, {'measure': 'Time to death', 'timeFrame': '4 years', 'description': 'Measure duration of survival of treated patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.', 'detailedDescription': 'This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas\n2. CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration\n3. CT chest or PET/CT within 6 weeks prior to registration\n4. Clinically determined to be resectable based on NCCN Criteria:\n5. No radiographic evidence of superior mesenteric vein or portal vein distortion\n6. No evidence of distant metastasis\n7. Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery\n8. No enlarged lymph nodes per CT criteria or PET avid lymph nodes\n9. No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)\n10. Adequate cardiopulmonary reserves to tolerate surgery\n11. Karnofsky performance status \\> 70\n12. Age \\>18\n13. Adequate bone marrow function defined as follows:\n14. Absolute neutrophil count (ANC) \\> 1800 cells/mm3\n15. Platelets ≥ 100,000 cells/mm3\n16. Hemoglobin \\> 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb \\> 8 g/dl is acceptable.)\n17. Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry\n18. Patient must sign study specific informed consent prior to study entry\n\nExclusion Criteria:\n\n1. Prior surgical resection of any pancreatic malignancy\n2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years\n3. Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.\n4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n5. Severe, active comorbidity, defined as follows:\n\n 1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months\n 2. Transmural myocardial infarction within the last 6 months\n 3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n 4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.\n6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure\n7. Any evidence of distant metastases (M1)\n8. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic"}, 'identificationModule': {'nctId': 'NCT02347618', 'briefTitle': 'Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'UGIP14107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative SBRT', 'description': 'This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.', 'interventionNames': ['Radiation: Preoperative SBRT']}], 'interventions': [{'name': 'Preoperative SBRT', 'type': 'RADIATION', 'description': 'This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.', 'armGroupLabels': ['Preoperative SBRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Alan W Katz, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alan Katz', 'investigatorAffiliation': 'University of Rochester'}}}}