Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT04408859
Status:
UNKNOWN
Last Update Posted:
2020-05-29
First Post:
2020-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-05-28', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life index', 'timeFrame': '2 years', 'description': 'The change of quality of life index during the 2 years after surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long term quality of life with advanced gastric cancer patients.', 'detailedDescription': 'Preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was included in the 2018 version of the National Comprehensive Cancer Network (NCCN) guideline as an optional treatment (category 2B) for prospective resectable advanced gastric cancer cases (≥cT2, any N).At home and abroad, the research on neoadjuvant chemotherapy for advanced gastric cancer mainly focuses on the safety and long-term survival, and there are few studies on the quality of life. This study, according to EORTC QLQ-C30 and QLQ-STO22 assessment scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in patients with advanced gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have had curative resection at Beijing Cancer Hospital for advanced gastric cancer and finish the questionnaire.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age older than 18 years (including 18 years old);\n* Diagnosis of adenocarcinoma of the stomach\n* The clinic stage is ≥T2 and any N stage\n* Patient had curative surgical resection, including proximal, distal, or total gastrectomy\n\nExclusion Criteria:\n\n* Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires\n* Non-psychiatric disorder causing a lack of capacity to give consent or an inability to complete questionnaires (ie dementia, stroke)\n* Early gastric cancer.'}, 'identificationModule': {'nctId': 'NCT04408859', 'briefTitle': 'Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Cancer Hospital & Institute'}, 'officialTitle': 'Quality of Life in Patient With Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'QOL-201804'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NACS', 'description': 'The patients with advanced gastric cancer who received neoadjuvant chemotherapy followed by surgery（NACS）.', 'interventionNames': ['Drug: Neoadjuvant Chemotherapy']}, {'label': 'SA', 'description': 'The patients with advanced gastric cancer who received surgery alone.'}], 'interventions': [{'name': 'Neoadjuvant Chemotherapy', 'type': 'DRUG', 'description': 'The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.', 'armGroupLabels': ['NACS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zaozao Wang', 'role': 'CONTACT', 'email': 'zaozao83630@sina.com', 'phone': '0086-10-88196851'}, {'name': 'Jianhong Yu', 'role': 'CONTACT', 'email': 'yjh1911110624@peu.edu.cn', 'phone': '0086-10-88196851'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zaozao Wang', 'role': 'CONTACT', 'email': 'zaozao83630@sina.com', 'phone': '0086-10-88196851'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Cancer Hospital & Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of GI surgery IV', 'investigatorFullName': 'Xiangqian Su', 'investigatorAffiliation': 'Peking University Cancer Hospital & Institute'}}}}