Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-05 @ 12:07 AM
Study NCT ID:
NCT00644618
Status:
COMPLETED
Last Update Posted:
2008-03-27
First Post:
2008-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy
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'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-24', 'studyFirstSubmitDate': '2008-03-24', 'studyFirstSubmitQcDate': '2008-03-24', 'lastUpdatePostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '2 years after the inclusion of the last patient'}], 'secondaryOutcomes': [{'measure': 'response rate, clinical benefit response, and safety', 'timeFrame': '2 month after the treatment finished'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatic cancer', 'locally advanced'], 'conditions': ['Locally Advanced Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'For patients with unresectable locally advanced pancreatic cancer, the combined use of external-beam radiation therapy (EBRT) and systemic chemotherapy of 5-FU has been widely recognized as the most effective chemoradiotherapy approach.But most patients succumb to local recurrence and metastasis after treatment, and the prognosis remains poor On the basis of the development and superiority of the interstitial brachytherapy and the radiosensitizing effect of gemcitabine, we performed a clinical study to explore the interaction of improved I-125 brachytherapy and gemcitabine and compare the regimen to the standard gemcitabine treatment specifically in patients with non-metastatic, unresectable pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically proven\n* locally advanced pancreatic adenocarcinoma stage\n* No systemic metastases\n* Age between 18-75\n* Karnofsky-Performance Status equal to, or greater than 70 %\n* At least a 2-dimensionally measurable tumor lesion\n* Adequate renal and liver function\n* Written consent statement\n* Patients' compliance and geographical proximity\n* Life expectancy equal to or greater than 3 months\n\nExclusion Criteria:\n\n* Serious psychological disease\n* Pregnancy and inadequate or not secure contraception or breastfeeding women\n* Other previous malignant disease in the past two years\n* Serious systemic concomitant diseases, excluding participation in a trial\n* Other experimental treatment during or within 6 weeks prior to this trial (including chemotherapeutic medicine or immune-therapies)\n* Every other condition or therapy assessed by the physician as an eventual risk for the patient or restricting the aims of the trial\n* Distant metastasis"}, 'identificationModule': {'nctId': 'NCT00644618', 'briefTitle': 'Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Randomized Controlled Trial of Gemcitabine Combined With 125I Brachytherapy Versus Gemcitabine Alone in Patients With Locally Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'Union Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Other: 125I brachytherapy PLUS gemcitabine']}], 'interventions': [{'name': 'gemcitabine', 'type': 'DRUG', 'description': 'a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3', 'armGroupLabels': ['A']}, {'name': '125I brachytherapy PLUS gemcitabine', 'type': 'OTHER', 'description': '125I brachytherapy PLUS a 30-minute intravenous infusions of gemcitabine 1,000 mg/m2 weekly×7, followed by a 1-week pause, and then weekly×3', 'armGroupLabels': ['B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'President Hu Yu', 'oldOrganization': 'Union hospital, Huazhong University of Science and Technology'}}}}