Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 11:30 PM
Study NCT ID:
NCT00005060
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
2000-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy and Surgery in Treating Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-14', 'studyFirstSubmitDate': '2000-04-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival'}], 'secondaryOutcomes': [{'measure': 'Overall survival'}, {'measure': 'Time to treatment failure measured after completion of study treatment'}, {'measure': 'Toxicity measured after completion of study treatment'}, {'measure': 'Rate of complete resection (RO) and postoperative mortality as measured after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II gastric cancer', 'stage III gastric cancer'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with surgery may kill more tumor cells. It is not yet known if chemotherapy followed by surgery is more effective than surgery followed by chemotherapy for stomach cancer.\n\nPURPOSE: This randomized phase III trial is studying surgery followed by combination chemotherapy to see how well it works compared to combination chemotherapy followed by surgery in treating patients with locally advanced stomach cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare, by intention to treat analysis, feasibility and efficacy of 4 courses of docetaxel, cisplatin, and fluorouracil as preoperative or postoperative chemotherapy in patients with locally advanced operable gastric carcinoma.\n* Evaluate the predictive values of some biological and molecular tumor parameters on response to chemotherapy, metastasis and survival in this patient population.\n\nOUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to study center, tumor site (affecting the Z-line (cardia carcinoma Siewart II and III) vs rest of the stomach), and nodal status (positive vs negative). Patients are randomized to either preoperative chemotherapy followed by surgery (arm I) or surgery followed by postoperative chemotherapy (arm II).\n\n* Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 4 hours on day 1, and fluorouracil IV continuously on days 1-14 every 3 weeks. Patients are evaluated after 2 courses and patients with progressive disease proceed to immediate surgery. Otherwise, treatment continues for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Between 3-5 weeks following day 1 of the last course of chemotherapy, patients undergo gastric resection.\n* Arm II: Patients undergo immediate gastric resection. Beginning 3-6 weeks after surgery, patients receive 4 courses of docetaxel, cisplatin, and fluorouracil as in arm I.\n\nQuality of life is assessed before the first and third courses of chemotherapy, before and after surgery, and then at 1, 3, and 6 months.\n\nPatients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: Approximately 240 patients (120 per arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed locally advanced gastric carcinoma that is considered operable\n\n * T3-4, Nx, M0 OR\n * Tx, N+, M0\n* Lymph nodes considered positive by sonography should be at least 2 of the following:\n\n * Round\n * Echopoor\n * Sharp borders\n * At least 0.5 cm\n* No distant metastases, including peritoneal carcinomatosis\n\n * CT scan and peritoneal lavage mandatory\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 75\n\nPerformance status:\n\n* 0-2\n\nLife expectancy:\n\n* Greater than 12 weeks\n\nHematopoietic:\n\n* WBC at least 4,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin normal\n* AST or ALT no greater than 1.5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2.5 times ULN\n\nRenal:\n\n* Adequate renal function within limits to allow for treatment with cisplatin\n\nCardiovascular:\n\n* No unstable cardiac disease requiring treatment\n* No congestive heart failure or angina pectoris even if medically controlled\n* No significant arrhythmias\n* No myocardial infarction within past 6 months\n* Ejection fraction greater than 50% on cardiac sonography or MUGA scan\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix\n* No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic)\n* No history of anaphylaxis\n* No other serious concurrent illness or medical condition that would preclude study therapy\n* No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures)\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent biologic therapy for gastric carcinoma\n\nChemotherapy:\n\n* No other concurrent chemotherapy for gastric carcinoma\n\nEndocrine therapy:\n\n* No concurrent endocrine therapy for gastric carcinoma\n\nRadiotherapy:\n\n* No concurrent radiotherapy for gastric carcinoma\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* At least 30 days since prior treatment in a clinical trial\n* No other concurrent experimental drugs\n* No other concurrent anticancer therapy'}, 'identificationModule': {'nctId': 'NCT00005060', 'briefTitle': 'Combination Chemotherapy and Surgery in Treating Patients With Locally Advanced Stomach Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Cancer Institute'}, 'officialTitle': 'A Phase III Trial of Preoperative vs. Postoperative Chemotherapy With Taxotere-Cisplatin-5FU (TCF) in Patients With Locally Advanced Operable Gastric Carcinoma', 'orgStudyIdInfo': {'id': 'SAKK 43/99'}, 'secondaryIdInfos': [{'id': 'SWS-SAKK-43/99', 'type': 'OTHER', 'domain': 'SAKK'}, {'id': 'EU-99042'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Taxotere-Cisplatin-5FU preoperatively', 'description': 'TCF preoperatively', 'interventionNames': ['Drug: Taxotere-Cisplatin-5FU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate surgery followed by TCF', 'description': 'Surgery followed by Taxotere-Cisplatin-5FU', 'interventionNames': ['Drug: Immediate surgery']}], 'interventions': [{'name': 'Taxotere-Cisplatin-5FU', 'type': 'DRUG', 'description': 'Preoperatively', 'armGroupLabels': ['Taxotere-Cisplatin-5FU preoperatively']}, {'name': 'Immediate surgery', 'type': 'DRUG', 'description': 'Immediate surgery followed by Taxotere-Cisplatin-5FU', 'armGroupLabels': ['Immediate surgery followed by TCF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': 'CH-1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hopital Cantonal Universitaire de Geneve', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'CH-9006', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Zentrum fuer Tumordiagnostikund Praevention', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Rudolf Morant, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tumor Zentrum ZeTup St. Gallen und Chur'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}