Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02506803
Status:
UNKNOWN
Last Update Posted:
2016-05-12
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline 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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with toxicity of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.', 'timeFrame': 'Up to 30 weeks.', 'description': 'Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.'}], 'secondaryOutcomes': [{'measure': 'The resection rate of NAC-GEMABR therapy as neoadjuvant chemothterapy for borderline resectable pancreatic cancer.', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'The R0 resection rate of NAC-GEMABR therapy as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.', 'timeFrame': 'Up to 30 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '28179342', 'type': 'DERIVED', 'citation': 'Okada KI, Hirono S, Kawai M, Miyazawa M, Shimizu A, Kitahata Y, Ueno M, Hayami S, Yamaue H. Phase I Study of Nab-Paclitaxel plus Gemcitabine as Neoadjuvant Therapy for Borderline Resectable Pancreatic Cancer. Anticancer Res. 2017 Feb;37(2):853-858. doi: 10.21873/anticanres.11389.'}]}, 'descriptionModule': {'briefSummary': 'Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen.', 'detailedDescription': 'Gemcitabine plus nub-paclitaxel (GEMABR) regimen was recently presented at an international oncology meeting and represents a new standard regimen in the treatment of metastatic pancreatic cancer. GEMABR is one of the high response rate treatment regimen, the investigators considered as a promising treatment as neoadjuvant chemotherapy . On the other hand , incidences of grade 3 or 4 neutropenia , febrile neutropenia and peripheral neuropathy were significantly higher in the g group compared with gemcitabine group. Therefore, it was decided to consider the balance of safety and efficacy as a preoperative chemotherapy, the investigators use the NAC-GEMABR regimen includes only two cycles (three times weekly and one week rest) of GEMABR regimen. The investigators also evaluate the optimal treatment schedule of NAC-GEMABR therapy as neoadjuvant chemotherapy, optimal duration between surgery and chemotherapy, R0 resection rate, and resection rate for borderline resectable pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically proven invasive pancreatic ductal carcinoma\n* Cases that meet the definition of borderline resectable pancreatic cancer 1) or 2)\n\n 1. Definition of a borderline resectable pancreatic cancer is filledin NCCN guideline version 1.2014 pancreatic adenocarcinoma\n 2. Patients indicated distal pancreatectomy with en bloc celiac axis resection\n* PS (ECOG) 0-1\n* ≧20 years old and \\< 80 years old\n* First line treatment\n* The following criteria must be satisfied in laboratory tests within 14 days of registration White blood cell count ≦12,000/mm3 Neutrophil count ≧1,500/mm3 Platelet count ≧100,000mm3 Total bilirubin \\<2.0mg/dL Serum Creatinine ≦upper limits of normal(ULN) AST, ALT≦2.5×ULN Albumin≧3.0g/dL Hemoglobin≧9.0g/dL\n* Written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Severe drug hypersensitivity\n* Multiple primary cancers within 5 years\n* Severe infection\n* With grade2 or more severe peripheral neuropathy\n* With intestinal paralysys, ileus\n* Interstitial pneumonia or pulmonary\n* With uncontrollable pleural effusion or ascites\n* Receiving atazanavir sulfate\n* With uncontrollable diabetes\n* With uncontrollable heart failure, angina, hypertension, arrhythmia\n* With severe psychological symptoms\n* With watery diarrhea\n* Pregnant or lactating women, or women with known or suspected pregnancy\n* Inappropriate patients for entry on this study in the judgment of the investigator'}, 'identificationModule': {'nctId': 'NCT02506803', 'briefTitle': 'Phase I Study of Neoadjuvant Chemotherapy for Patients With Borderline Resectable Pancreatic Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Wakayama Medical University'}, 'officialTitle': 'Phase I Study of Neoadjuvant Chemotherapy of Gemcitabine Plus Nab-paclitaxel for Patients With Borderline Resectable Pancreatic Cancer.', 'orgStudyIdInfo': {'id': 'NAC-GEMABR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAC-GEMABR', 'description': 'Neoadjuvant chemotherapy 2 courses of NAC-GEMABR for subsequent 10 patients.', 'interventionNames': ['Drug: NAC-GEMABR']}], 'interventions': [{'name': 'NAC-GEMABR', 'type': 'DRUG', 'otherNames': ['Gemcitabine, nab-paclitaxel'], 'description': 'NAC-GEMABR regimen includes gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 3 times weekly 1week rest.', 'armGroupLabels': ['NAC-GEMABR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641-8510', 'city': 'Wakayama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroki Yamaue, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ken-ichi Okada, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manabu Kawai, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seiko Hirono, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Motoki Miyazawa, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Atsushi Shimizu, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yuji Kitahata, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Wakayama Medical University', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'centralContacts': [{'name': 'Hiroki Yamaue, M.D., PhD', 'role': 'CONTACT', 'email': 'yamaue-h@wakayama-med.ac.jp', 'phone': '+81-73-441-0613', 'phoneExt': '5112'}], 'overallOfficials': [{'name': 'Hiroki Yamaue, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wakayama Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wakayama Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dean & Professor of the second department of surgery', 'investigatorFullName': 'Hiroki Yamaue', 'investigatorAffiliation': 'Wakayama Medical University'}}}}