Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-31 @ 2:05 PM
Study NCT ID:
NCT03977220
Status:
UNKNOWN
Last Update Posted:
2019-06-06
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recommended dose for Phase II study', 'timeFrame': 'through study completion, an average of 2 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '35751496', 'type': 'DERIVED', 'citation': "Cui Y, Yu Y, Yu S, Li W, Wang Y, Li Q, Liu T. Phase I study of adjuvant chemotherapy with nab-paclitaxel and S-1 for stage III Lauren's diffuse-type gastric cancer after D2 resection (NORDICA study). Cancer Med. 2023 Jan;12(2):1114-1121. doi: 10.1002/cam4.4966. Epub 2022 Jun 25."}]}, 'descriptionModule': {'briefSummary': 'Investigators assessed the effectiveness of Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting', 'detailedDescription': 'Adjuvant chemotherapy is still the standard of care for stage Ⅲ gastric cancer. Till now, oxaliplatin with capecitabine or S1 still the standard chemotherapy regimen. Howerver, the prognosis of diffuse type gastric cancer patients is still poor even after adjuvant chemotherapy of XELOX or S1 regimen. Several retrospective, single institutional studies have shown that the addition of Nab-paclitaxel to S1 can prolong the survival of advanced gastric cancer with diffuse type.However, the effection of Nab-paclitaxel and S1 is unknown in diffuse gastric cancer patients after radical surgery. We assessed the effectiveness of radical surgery following docetaxel, nab-pacitaxel and S1 therapy for gastric cancer with diffuse type.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gastric cancer patients after radical resection\n* diffuse type gastric cancer stage III\n\nExclusion Criteria:\n\n* Patients who have metastasis disease\n* Patients who can not tolerate chemotherapy'}, 'identificationModule': {'nctId': 'NCT03977220', 'briefTitle': 'Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Phase I Study: Nab-paclitaxel Combined With S-1 Treating Diffuse Type of Stage Ⅲ Gastric Cancer as Adjuvant Setting (NORDICA)', 'orgStudyIdInfo': {'id': 'NORDICA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nab-paclitaxel combined with S-1', 'description': 'Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting', 'interventionNames': ['Drug: Nab-paclitaxel combined with S-1']}], 'interventions': [{'name': 'Nab-paclitaxel combined with S-1', 'type': 'DRUG', 'description': 'Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting', 'armGroupLabels': ['Nab-paclitaxel combined with S-1']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman for the department of oncology', 'investigatorFullName': 'Tianshu Liu', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}