Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04694404
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2017-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment Eledrly Patients with Untreated Advanced or Recurrent Gastric Cancer'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2017-11-05', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '6 months', 'description': 'Progression-free survival'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': '6 months', 'description': 'Objective response rate'}, {'measure': 'OS', 'timeFrame': '1 year', 'description': 'Overall survival'}, {'measure': 'The number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '1 year', 'description': 'Safety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['S-1,Oxaliplatin,Advanced or Recurrent Gastric Cancer'], 'conditions': ['S-1 Plus Oxaliplatin']}, 'referencesModule': {'references': [{'pmid': '35264150', 'type': 'DERIVED', 'citation': 'Jiang Z, Zhou A, Sun Y, Zhang W. Biweekly oxaliplatin plus S1 for Chinese elderly patients with advanced gastric or gastroesophageal junction cancer as the first-line therapy: a single-arm, phase 2 study. BMC Cancer. 2022 Mar 9;22(1):253. doi: 10.1186/s12885-022-09332-7.'}]}, 'descriptionModule': {'briefSummary': 'Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.', 'detailedDescription': '3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area \\< 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area \\>1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma;\n* Aged≥60\n* ability of oral administration;\n* CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1);\n* Untreated\n* more than 12 months after the last adjuvant/neoadjuvant chemotherapy;\n* ECOG=0-2;\n* Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min\n* Informed consent;\n* Expected survival more than 3 months;More than 3 weeks after major surgery.\n\nExclusion Criteria:\n\n* Neoadjuvant and/or adjuvant have been treated with more than two plans;\n* In the past two years, the total dose of oxaliplatin≥800mg/m2;\n* Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer;\n* Symptomatic brain metastases or soft meningeal metastasis;\n* Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure;\n* Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃;\n* Known allergy to drugs in the study;\n* Pregnant or lactating women;\n* Both male and female subjects of potential fertility have to agree effective birth control during the entire study;\n* Experimental drugs used no more than 4 weeks;\n* Other conditions the researchers considered ineligible for the study.'}, 'identificationModule': {'nctId': 'NCT04694404', 'briefTitle': 'Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced Gastric Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'The Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced or Recurrent Gastric Cancer', 'orgStudyIdInfo': {'id': 'CH-PI-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-1 Plus Oxaliplatin', 'description': 'Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \\< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \\>1.5 m2; D1-10, q2w)', 'interventionNames': ['Drug: S-1,Oxaliplatin']}], 'interventions': [{'name': 'S-1,Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area \\< 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area \\>1.5 m2; D1-10, q2w)', 'armGroupLabels': ['S-1 Plus Oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aiping Zhou, Doctor', 'role': 'CONTACT', 'email': 'zhouap1825@126.com', 'phone': '+86 13691161998'}, {'name': 'Aiping Zhou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center/Cancer Hospital, Chinese ACademy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Aiping Zhou, Doctor', 'role': 'CONTACT', 'email': 'zhouap1825@126.com', 'phone': '+86 13691161998'}], 'overallOfficials': [{'name': 'Aiping Zhou, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aiping Zhou', 'class': 'UNKNOWN'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Aiping Zhou', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}