Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT01412294
Status:
UNKNOWN
Last Update Posted:
2017-07-27
First Post:
2011-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
XParTS: Capecitabine/Cisplatin(XP) for Recurrent 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': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2011-07-30', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 year'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 year'}, {'measure': 'Response rate', 'timeFrame': '2 year'}, {'measure': 'Time to treatment failure', 'timeFrame': '2 year'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '2 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric cancer', 'recurrent gastric cancer', 'adenocarcinoma of the stomach', 'capecitabine', 'xp'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '29488122', 'type': 'DERIVED', 'citation': 'Nishikawa K, Tsuburaya A, Yoshikawa T, Takahashi M, Tanabe K, Yamaguchi K, Yoshino S, Namikawa T, Aoyama T, Rino Y, Kawada J, Tsuji A, Taira K, Kimura Y, Kodera Y, Hirashima Y, Yabusaki H, Hirabayashi N, Fujitani K, Miyashita Y, Morita S, Sakamoto J. A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial. Gastric Cancer. 2018 Sep;21(5):811-818. doi: 10.1007/s10120-018-0815-0. Epub 2018 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.', 'detailedDescription': 'S-1/Cisplatin (SP) is one of the standard treatments of advanced gastric cancer. However, evidence of SP on gastric cancer recurrence after adjuvant therapy by the same drug (S-1) is not established. The aim of this study is to evaluate the efficacy and safety of Capecitabine/Cisplatin (XP) for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Recurrent gastric cancer histologically confirmed as being adenocarcinoma\n2. Age of 20 to 74 years with either gender\n3. ECOG Performance Status of 0 to 2\n4. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)\n5. Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period\n6. Less than 6 months treatment-free interval from completion of adjuvant therapy\n7. In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2\n8. Treatment-naïve recurrent gastric cancer\n9. Life expectancy of at least 3 months after registration\n10. Written informed consent\n11. Adequate major organ functions within 14 days before registration\n\n Exclusion Criteria:\n12. Positive HER2 status\n13. Previous treatment with platinum agents after curative surgery\n14. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents\n15. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency\n16. More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.\n17. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)\n18. Active hepatitis\n19. Heart disease that is serious or requires hospitalization, or history of such disease within past year\n\n9\\) Concurrent illness that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)\n\n10\\) Being treated or in need of treatment with phenytoin or warfarin potassium\n\n11\\) Chronic diarrhea (watery stool or ≥ 4 times/day)\n\n12\\) Active gastrointestinal hemorrhage\n\n13\\) Body cavity fluids requiring drainage or other treatment\n\n14\\) Clinical suspicion or previous history of metastases to brain or meninges\n\n15\\) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16) Unwillingness to practice contraception\n\n17\\) Poor oral intake\n\n18\\) Psychiatric disorders which are being or may need to be treated with psychotropics\n\n19\\) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study'}, 'identificationModule': {'nctId': 'NCT01412294', 'briefTitle': 'XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Epidemiological and Clinical Research Information Network'}, 'officialTitle': 'Phase II Study to Evaluate Efficacy and Safety of Capecitabine/Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy (XParTS)', 'orgStudyIdInfo': {'id': 'ECRIN-GC1106-XParTS'}, 'secondaryIdInfos': [{'id': 'UMIN000005857', 'type': 'OTHER', 'domain': 'UMIN Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Capecitabine, Cisplatin', 'interventionNames': ['Drug: Capecitabine, Cisplatin']}], 'interventions': [{'name': 'Capecitabine, Cisplatin', 'type': 'DRUG', 'description': 'Drug: Capecitabine Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.\n\nDrug: Cisplatin Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.', 'armGroupLabels': ['Capecitabine, Cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '606-8392', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Epidemiological and Clinical Research Information Network', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}], 'overallOfficials': [{'name': 'Akira Tsuburaya', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shonan Kamakura Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epidemiological and Clinical Research Information Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}