Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT01286766
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2011-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma
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': 'D003523', 'term': 'Cycloserine'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C103828', 'term': 'titanium silicide'}, {'id': 'D015649', 'term': 'Pentostatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003070', 'term': 'Coformycin'}, {'id': 'D005573', 'term': 'Formycins'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2011-01-27', 'studyFirstSubmitQcDate': '2011-01-28', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RECIST(Response Evaluation Criteria in Solid Tumors)', 'timeFrame': 'written in the description part below', 'description': '* safety : every cycle adverse event/serious adversr event evaluation from NCI-CTC(version 3.0)\n* efficacy : tumor response is assessed every 2 cycles (6weeks) -\\> tumor response assessment(RECIST\\<Response Evaluation Criteria in Solid Tumor\\> 1.0 version use)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['unresectable', 'locally advanced'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': "Number of patients planned The study adopted two parallel phase II studies, with the same P1 and P0 in each arm, suggested by Logan. The investigators hypothesized a target ORR of interest, P1=50, and a lower ORR, P0=25 with the treatment of DCS and DCF, respectively. Under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of A'Hern, 26 patients were required per arm to achieve the desired statistical power. Finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.", 'detailedDescription': "Treatment scheme\n\n* Screening period: D-21 to D1 (treatment day)\n* Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT scan.\n* Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer Association (JGCA, 1998)\n* Tumor response is assessed every 2 cycles (6 weeks)\n* Treatment is repeated until,.\n\n * 4 cycles\n * progressive disease\n * unacceptable toxicity\n * patient's withdrawal\n* Gastric surgery should be performed within 4\\~6 weeks of the last dose of chemotherapy\n* Gastric surgery is for curative aim and should include ≥ D2 LN dissection.\n* Patients who received R0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-FU and cisplatin.\n* Palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-FU and oxaliplatin combination is recommended as first-line therapy.\n* Follow up for survival is repeated every 3 months for 2 years\n\nStudy period Patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically/cytologically confirmed gastric adenocarcinoma\n* Age 18 to 70 years old\n* ECOG performance Status 0\\~1\n* Preoperative clinical staging by Japanese Gastric Cancer Association (JGCA): cT3N2 (IIIB), cT4N0-3 (IIIA\\~IV), M0, P0, H0, CY0\n* No pretreatment (radiotherapy or chemotherapy) for gastric cancer\n* Adequate organ function\n\n * Hb ≥ 9.0 g/dL\n * WBC ≥ 4,000/µL\n * ANC ≥ 2,000/µL (\\*ANC = Neutrophil segs ＋ Neutrophil bands)\n * Platelet ≥ 100 × 103/ µL\n * Total bilirubin: ≤ 1.5 × UNL\n * CCr ≥ 60 ml/min (by laboratory or Cockcroft-Gault Formula)\n * AST/ALT, ALP: ≤ 2.5 × UNL\n* Written informed consent\n\nExclusion Criteria:\n\n* Distant metastasis on diagnosis\n* cT1-2\n* Cancer of gastroesophageal junction (GEJ)\n* Poor oral intake or absorption deficiency syndrome\n* Gastric outlet obstruction, perforation or bleeding\n* Medically uncontrollable chronic illness or infection\n* Pregnant or lactating women, women of childbearing potential not employing adequate contraception\n* History of clinically significant cardiac disease\n* Past or concurrent history of neoplasm last \\< 5 year other than gastric cancer\n* Prior gastrectomized patients\n* Concomitant administration of any other experimental drug under investigation\n* Peripheral neuropathy ≥ NCI-CTC grade 2'}, 'identificationModule': {'nctId': 'NCT01286766', 'briefTitle': 'Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma', 'orgStudyIdInfo': {'id': '4-2009-0332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DCS', 'description': 'DCS: docetaxel with cisplatin with TS-1', 'interventionNames': ['Drug: DCS (docetaxel with cisplatin with TS-1)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DCF', 'description': 'DCF : docetaxel with cisplatin with 5-FU', 'interventionNames': ['Drug: DCF (docetaxel with cisplatin with 5-FU)']}], 'interventions': [{'name': 'DCS (docetaxel with cisplatin with TS-1)', 'type': 'DRUG', 'otherNames': ['Taxotere', 'CDDP', 'TS-1'], 'description': '1. S-1: 70 mg/m2 #2 bid PO, D1-14\n2. Docetaxel 30 mg/m2 IVF (for 1 hr) D1 and D8\n3. Cisplatin 30 mg/m2 IVF (for 2 hrs, without hydration) D1 and D8, repeated by 3 weeks.', 'armGroupLabels': ['DCS']}, {'name': 'DCF (docetaxel with cisplatin with 5-FU)', 'type': 'DRUG', 'otherNames': ['5-FU', 'Taxotere', 'CDDP'], 'description': '1. 5-FU: 1,000 mg/m2 CI, D1-3\n2. Docetaxel 60 mg/m2 IVF (for 1 hr) D1 followed by\n3. Cisplatin 60 mg/m2 IVF (for 2 hrs, with hydration) D1, repeated by 3 weeks.\n\n * Intercycle or intracycle dose modification is indicated if ≥G3 hematologic toxicity (except anemia) or ≥G3 non-hematologic toxicity (except alopecia)\n * treatment is repeated until 4 cycles', 'armGroupLabels': ['DCF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-750', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}