Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-06 @ 9:51 PM
Study NCT ID:
NCT00134095
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2005-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach 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': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2005-08-22', 'studyFirstSubmitQcDate': '2005-08-22', 'lastUpdatePostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor shrinkage'}, {'measure': 'Historical tumor shrinkage'}, {'measure': 'Overall survival'}, {'measure': 'Progression-free survival'}, {'measure': 'Median survival'}, {'measure': 'Safety'}]}, 'conditionsModule': {'keywords': ['adenocarcinoma of the stomach', 'stage II gastric cancer', 'stage III gastric cancer', 'stage IV gastric cancer'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as S-1 and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be completely removed.\n\nPURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.\n\nSecondary\n\n* Determine the histological response in patients treated with this regimen.\n* Determine the overall survival of patients treated with this regimen.\n* Determine the progression-free survival of patients treated with this regimen.\n* Determine the toxicity of this regimen in these patients.\n* Determine postoperative morbidity in patients treated with this regimen.\n* Determine the rate of potentially curative surgery in patients treated with this regimen.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After surgery, patients resume treatment with S-1 alone as before for 1 year.\n\nPROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed gastric adenocarcinoma\n\n * Locally advanced disease\n\n * Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)\n* Planning to undergo curative surgery after neoadjuvant chemotherapy\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 20 to 75\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC 4,000-12,000/mm\\^3\n* Granulocyte count ≥ 2,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Hemoglobin ≥ 9.0 g/dL\n\nHepatic\n\n* AST and ALT ≤ 100 U/L\n* Bilirubin ≤ 1.5 mg/dL\n\nRenal\n\n* Creatinine normal OR\n* Creatinine clearance ≥ 50 mL/min\n\nPulmonary\n\n* PaO\\_2 \\> 60 mm Hg on room air\n\nOther\n\n* Able to swallow oral medication\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior biologic therapy for gastric cancer\n\nChemotherapy\n\n* No prior chemotherapy for gastric cancer\n\nEndocrine therapy\n\n* No prior endocrine therapy for gastric cancer\n\nRadiotherapy\n\n* No prior radiotherapy for gastric cancer\n\nSurgery\n\n* No prior surgery for gastric cancer\n\nOther\n\n* No other prior therapy for gastric cancer'}, 'identificationModule': {'nctId': 'NCT00134095', 'briefTitle': 'S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'CDR0000439474'}, 'secondaryIdInfos': [{'id': 'FMUH-UHA-GC04-02'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'irinotecan hydrochloride', 'type': 'DRUG'}, {'name': 'tegafur-gimeracil-oteracil potassium', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '016-0014', 'city': 'Noshiro', 'state': 'Akita', 'country': 'Japan', 'facility': 'Yamamoto Kumiai General Hospital', 'geoPoint': {'lat': 40.20838, 'lon': 140.0274}}, {'zip': '960-1295', 'city': 'Fukushima', 'state': 'Fukushima', 'country': 'Japan', 'facility': 'Fukushima Medical University Hospital', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '078-8211', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Asahikawa Kosei General Hospital', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '650', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe City General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '020-8505', 'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Iwate Medical University Hospital', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'zip': '997-8515', 'city': 'Tsuruoka', 'state': 'Yamagata', 'country': 'Japan', 'facility': 'Tsuruoka Municipal Shonai Hospital', 'geoPoint': {'lat': 38.72167, 'lon': 139.82167}}, {'zip': '990-2292', 'city': 'Yamagata', 'state': 'Yamagata', 'country': 'Japan', 'facility': 'Yamagata Prefectural Central Hospital', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}], 'overallOfficials': [{'name': 'Mitsukazu Gotoh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fukushima Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fukushima Medical University Hospital', 'class': 'OTHER'}}}}