Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT02481635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2015-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced 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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type and the severity of side effects', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Number of surviving patients at 1 year after treatment', 'timeFrame': '1 year'}, {'measure': 'Number of patients who disease has not progressed', 'timeFrame': '2 years'}, {'measure': 'Number of patients that are able to receive surgery after chemoradiation', 'timeFrame': '5 years'}, {'measure': 'Average length of hospital stay per patient', 'timeFrame': '5 years'}, {'measure': 'Number of surviving patients at 30-days after surgery', 'timeFrame': '30 days after surgery'}, {'measure': 'Number of surviving patients at 90-days after surgery', 'timeFrame': '90 days after surgery'}, {'measure': 'Number of patients who need to be re-admitted to the hospital at 90-days after surgery', 'timeFrame': '90 days after surgery'}, {'measure': 'Time to Progression', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood Vessels', 'Reconstructive Surgery'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.', 'detailedDescription': 'Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSurgical:\n\n* Medically fit for major pancreatic surgery\n* No evidence of metastases\n* No prior resection\n* Arterial involvement limited to a single major vessel and is resectable\n* Tumour-free margins could be achieved\n* Acceptable length of vessel\n* Mass considered otherwise resectable by current standards\n\nGeneral:\n\n* Less than 70 years old\n* Performance status \\<=2\n* Has pancreatic adenocarcinoma\n* Adequate bone marrow and organ function\n* Therapeutic heparin is allowed\n* Taking chronic erythropoietin are permitted\n* Not pregnant\n* Agree to use contraception\n* Able to provide written consent\n\nExclusion Criteria:\n\nSurgical:\n\n* Aortic involvement\n* Involvement of 2 major arterial trunks\n* SMV/portal venous occlusion, cannot be reconstructed\n* Extensive venous involvement, no arterial involvement\n* Disease progression on neo-adjuvant treatme\n\nGeneral:\n\n* Concurrent cancer diagnosis\n* Other malignancies unless all therapy completed, no disease for \\>=3 years\n* Prior radiotherapy or chemo within 1 year, to pancreas\n* Bone marrow transplant/stem cell rescue\n* Major surgery \\<4 wks prior\n* Distant metastases\n* Renal dysfunction\n* Pulmonary insufficiency\n* History of cardiac disease\n* Active systemic infection(s) or any other related illnesses\n* Known HIV, HBV, HCV\n* History of solid organ transplant, cardiovascular disease, inflammatory bowel disease, or underlying neuropathy\n* Conditions interfering with patient participation\n* Known or suspected allergy to study drugs\n* Pregnant or breast-feeding\n* Therapeutic coumadin\n* More than or equal to Grade 2 pre-exiting peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT02481635', 'briefTitle': 'A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCAP) in Patients With Advanced Disease', 'orgStudyIdInfo': {'id': 'ARCAP-GA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine/Nab-paclitaxel, Radiation and Surgery', 'description': 'Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles.\n\nNab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles.\n\nRadiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction)\n\nSurgery: Tumor resection and arterial resection/reconstruction', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Nab-paclitaxel', 'Radiation: Radiation Therapy', 'Procedure: Surgical Resection']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'armGroupLabels': ['Gemcitabine/Nab-paclitaxel, Radiation and Surgery']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane'], 'armGroupLabels': ['Gemcitabine/Nab-paclitaxel, Radiation and Surgery']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'armGroupLabels': ['Gemcitabine/Nab-paclitaxel, Radiation and Surgery']}, {'name': 'Surgical Resection', 'type': 'PROCEDURE', 'armGroupLabels': ['Gemcitabine/Nab-paclitaxel, Radiation and Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Neesha Dhani, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}