Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-06 @ 5:51 AM
Study NCT ID:
NCT01760694
Status:
TERMINATED
Last Update Posted:
2014-08-15
First Post:
2012-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2012-12-26', 'studyFirstSubmitQcDate': '2013-01-02', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - Progression Free Survival', 'timeFrame': '2 years after last patient enrolled', 'description': 'Interim analysis at specific time points. Measure disease response by CT scans per standard of care or when clinically indicated.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '2 years after last patient enrolled', 'description': 'Interim analysis at certain time points. Measure disease response by CT scans per standard of care or when clinically indicated. Collect adverse events and serious adverse events. Collect quality of life data.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreatic', 'Pancreas', 'Intraoperative Radiation Therapy', 'Chemotherapy'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancercenter.com', 'label': 'Facility website address'}]}, 'descriptionModule': {'briefSummary': 'To assess the ability of a combination of updated and approved modalities in the treatment of first line pancreatic cancer patients to increase the time to Progression Free Survival', 'detailedDescription': 'For resectable patient; surgery with Intraoperative Radiation Therapy (IORT). Radiation Therapy within 6-8 weeks after surgery followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery.\n\nFor marginally resectable patients; the patients will have 2-3 cycles of neoadjuvant chemotherapy of FOLFIRINOX and then restaged, undergo surgery with IORT within 2-4 weeks following chemotherapy. Then radiation therapy starting within 6-8 weeks. Followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery for a total of 2-4 cycles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven Exocrine Adenocarcinoma of the pancreas\n* Clinically resectable or marginally resectable disease\n* No prior radiation or chemotherapy for carcinoma of the pancreas\n* ECOG performance status of 0-1\n* Patients must be medically able to undergo surgical resection\n* Patients of child bearing potential must follow study specific precautions\n* Women that are lactating will not be excluded on the condition that they dispose their breast milk.\n* Adequate hematologic and biochemical parameters.\n\nExclusion Criteria:\n\n* Prior treatment for pancreatic cancer.\n* Concurrent investigational treatments.\n* Unresectable pancreatic mass.\n* Neuroendocrine Histological pancreatic cancer\n* Distant Metastatic disease\n* Any condition that, in the option of the investigator, would compromise the well being of the patient or anything that would prevent the patient from meeting or performing study requirements'}, 'identificationModule': {'nctId': 'NCT01760694', 'briefTitle': 'Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Southwestern Regional Medical Center'}, 'officialTitle': 'Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'SRMC 12-08'}, 'secondaryIdInfos': [{'id': 'IORT Pancreatic', 'type': 'OTHER', 'domain': 'Cancer Treatment Centers of America'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resectable Patients', 'description': 'Surgery with Intraoperative Radiation Therapy (IORT). Radiation Therapy within 6-8 weeks after surgery followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery', 'interventionNames': ['Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Marginally Resectable Patients', 'description': '2-3 cycles of neoadjuvant FOLFIRINOX then restaged, then undergo surgery with Intraoperative Radiation Therapy (IORT) within 2-4 weeks following chemotherapy. Then Radiation Therapy within 6-8 weeks followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery for a total of 2-4 cycles', 'interventionNames': ['Other: Multi-Modality; IORT, Surgery, Radiation, Chemotherapy']}], 'interventions': [{'name': 'Multi-Modality; IORT, Surgery, Radiation, Chemotherapy', 'type': 'OTHER', 'otherNames': ['Intraoperative Radiation Therapy (IORT)', 'Chemotherapy: FOLFIRINOX, Oxaliplatin, Irinotecan, 5-FU, Leucovorin', 'Surgery: Resectable or Marginally Resectable'], 'armGroupLabels': ['Marginally Resectable Patients', 'Resectable Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74133', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Southwestern Regional Medical Center, Inc.', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Theodore Pollock, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southwestern Regional Medical Center, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwestern Regional Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}