Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-30 @ 8:12 AM
Study NCT ID:
NCT03882866
Status:
UNKNOWN
Last Update Posted:
2020-02-06
First Post:
2019-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iodine-125 Seed Implantation Therapy for Locally 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': '24 months', 'description': 'ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR). Responses are based on assessments per RECIST 1.1.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '24 months', 'description': 'OS is defined as the time from randomization to death due to any cause, or censored at date last known alive.'}, {'measure': 'Incidence of treatment-emergent toxicities of two treatment regimens in patients', 'timeFrame': '24 months', 'description': 'The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) were applied to assess the acute and late adverse effects of irradiation.'}, {'measure': 'Quality of life of two treatment regimens in patients', 'timeFrame': '24 months', 'description': 'Quality of life will be evaluated using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)C30 Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iodine-125', 'Three-Dimensional Printing', 'Brachytherapy', 'template'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This study evaluates the application of 3D-printed template for iodine-125 seed implantation therapy in patients with locally advanced pancreatic cancer. Half of participants will receive 3D-printed coplanar template, while the other half will receive 3D-printed non-coplanar template.', 'detailedDescription': 'Dosimetric verification was performed after implantation. Pre- and postoperative D90, V100, and V150 were calculated. The success rate of iodine-125 seed implantation, dosimetric parameters, objective response rate (ORR)，overall survival (OS)，toxicities and quality of life of two treatment regimens and complications were analyzed and compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-80 years\n* Cytologically or histologically confirmed pancreatic adenocarcinoma\n* Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)\n* Single tumor size≤ 6 cm\n* Karnofsky performance score （KPS）≥60\n* Estimated survival ≥3 months\n* Without other several comorbidity\n* Participants must have adequate organ function:\n\n * WBC≥3×109/L; HGB≥90g/dL; PLT≥50×109/L\n * Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal\n * Albumin≥3g/dL\n * Total bilirubin ≤3mg/dL\n * PT≤3 × institutional upper limit of normal or INR≤2.3\n * Creatinine ≤1.5 × institutional upper limit of normal\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients with other malignant tumors\n* History of other anti-cancer therapy, including surgery,radiation, ablation and so on\n* Pregnant or lactating women\n* Patients with Immunodeficiency disease\n* Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure，active coronary heart disease and severe arrhythmia\n* Uncontrolled hypertension\n* Ongoing or active infection (\\>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)\n* Active tuberculosis\n* Chronic renal insufficiency\n* Other organ failure\n* History of organ transplantation\n* History of severe mental illness'}, 'identificationModule': {'nctId': 'NCT03882866', 'briefTitle': 'Iodine-125 Seed Implantation Therapy for Locally Advanced Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': '3D-printed Template for Iodine-125 Seed Implantation Therapy in Patients With Locally Advanced Pancreatic Cancer: a Multicenter Study', 'orgStudyIdInfo': {'id': '2018clinicethicreview215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D-printed non-coplanar template', 'description': '3D-printed non-coplanar template is used in this group.', 'interventionNames': ['Procedure: 3D-printed non-coplanar template']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3D-printed coplanar template', 'description': '3D-printed coplanar template is used in this group.', 'interventionNames': ['Procedure: 3D-printed coplanar template']}], 'interventions': [{'name': '3D-printed non-coplanar template', 'type': 'PROCEDURE', 'description': '3D-printed non-coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed non-coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed non-coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.', 'armGroupLabels': ['3D-printed non-coplanar template']}, {'name': '3D-printed coplanar template', 'type': 'PROCEDURE', 'description': '3D-printed coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.', 'armGroupLabels': ['3D-printed coplanar template']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weifu Lv', 'role': 'CONTACT'}], 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yueyong Xiao, MD', 'role': 'CONTACT'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fujun Zhang, MD', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Juan Wang, MD', 'role': 'CONTACT'}], 'facility': 'Hebei General Hospital', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinhe Guo, MD', 'role': 'CONTACT'}], 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuliang Li, MD', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Zaozhuang', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kaixian Zhang, MD', 'role': 'CONTACT'}], 'facility': "Teng Zhou Central People's Hospital", 'geoPoint': {'lat': 34.86472, 'lon': 117.55417}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Zhao', 'role': 'CONTACT'}], 'facility': 'Huadong Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhongmin Wang, MD', 'role': 'CONTACT', 'email': 'wzm0722@hotmail.com', 'phone': '0086-13901848333'}, {'name': 'Qungang Shan, MD', 'role': 'CONTACT', 'email': 'qungangshan@sjtu.edu.cn', 'phone': '0086-15989037568'}], 'overallOfficials': [{'name': 'Zhongmin Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hebei General Hospital', 'class': 'OTHER'}, {'name': 'Zhongda Hospital', 'class': 'OTHER'}, {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Huadong Hospital', 'class': 'OTHER'}, {'name': "Tengzhou Central People's Hospital", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhongmin Wang', 'investigatorAffiliation': 'Ruijin Hospital'}}}}