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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000003688 |
Receipt No. | R000004380 |
Scientific Title | A phase III trial to evaluate bursectomy for patients with SS/SE gastric cancer (JCOG1001, BURSECTOMY PHASE III) |
Date of disclosure of the study information | 2010/06/01 |
Last modified on | 2015/03/30 |
Basic information | ||
Public title | A phase III trial to evaluate bursectomy for patients with SS/SE gastric cancer (JCOG1001, BURSECTOMY PHASE III) | |
Acronym | A phase III trial to evaluate bursectomy for patients with SS/SE gastric cancer (JCOG1001, BURSECTOMY PHASE III) | |
Scientific Title | A phase III trial to evaluate bursectomy for patients with SS/SE gastric cancer (JCOG1001, BURSECTOMY PHASE III) | |
Scientific Title:Acronym | A phase III trial to evaluate bursectomy for patients with SS/SE gastric cancer (JCOG1001, BURSECTOMY PHASE III) | |
Region |
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Condition | ||
Condition | cT3(SS) or cT4a(SE) gastric cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the efficacy and safety of bursectomy for cT3(SS) or cT4a(SE) gastric cancer patients. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Overall survival |
Key secondary outcomes | Progression-free survival, blood loss, operation time, surgical complications, adverse events of adjuvant chemotherapy |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | NO |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | A: non-bursectomy | |
Interventions/Control_2 | B: bursectomy | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1st inclusion criteria (before surgery)
1) Histologically proven primary gastric adenocarcinoma 2) cT3(SS)-T4b(SI) 3) cN0-2 H0 P0 M0 and not bulky N2 4) Possible for R0 surgery 5) Not Borrmann type 4 and not large (8cm or less) type 3 6) Length of esophageal invasion less or equal to 3cm 7) Not stump cancer of stomach 8) No history of upper abdominal surgery and no history of intestinal resection 9) No prior treatment of chemotherapy or radiation therapy against any other malignancies 10) Aed 20 to 80 years old 11) PS(ECOG) of 0 or 1 12) Body mass index is less than 30 13) Adequate organ functions defined as indicated below; i) WBC is 3,000/mm3 or more ii) Platelet is 100,000/mm3 or more iii) AST is 100 IU/L or less iv) ALT is 100 IU/L or less v) T.Bil is 2.0 mg/dL or less vi) Cr is 1.5 mg/dL or less 14) Written informed consent from patient 2nd inclusion criteria (during surgery) 1) cT3(SS) or cT4a(SE) 2) cN0-2 H0 P0 M0 3) Possible for R0 or R1 suregry due to only CY1 4) No need of thoracotomy for resection 5) Possible for bursectomy |
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Key exclusion criteria | 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2) Infectious disease with systemic therapy indicated 3) Body temperature is higher than 38 degrees centigrade 4) Women during pregnancy or breast-feeding 5) Severe mental disease 6) Continuous systemic steroid therapy 7) Unstable angina pectoris or history of myocardial infarction within 6 months 8) Uncontrollable hypertension 9) Uncontrollable diabetes millutus or administration of insulin 10) Severe respiratory disease requiring continuous oxygen therapy |
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Target sample size | 1200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka University Graduate School of Medicine | ||||||
Division name | Department of Gastroenterological Surgery | ||||||
Zip code | |||||||
Address | 2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan | ||||||
TEL | 06-6879-3251 | ||||||
ydoki@surg.med.osaka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | JCOG1001 Coordinating Office | ||||||
Division name | Osaka University Graduate School of Medicine, Department of Gastroenterological Surgery | ||||||
Zip code | |||||||
Address | 2-2-E2, Yamadaoka, Suita, Osaka, 565-0871, Japan | ||||||
TEL | 06-6879-3251 | ||||||
Homepage URL | http://www.jcog.jp/ | ||||||
JCOG_sir@ml.jcog.jp |
Sponsor | |
Institute | Japan Clinical Oncology Group (JCOG) |
Institute | |
Department |
Funding Source | |
Organization | Ministry of Health, Labour and Welfare |
Organization | |
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Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 函館厚生院函館五稜郭病院(北海道)
恵佑会札幌病院(北海道) 岩手医科大学(岩手県) 国立病院機構仙台医療センター(宮城県) 宮城県立がんセンター(宮城県) 山形県立中央病院(山形県) 栃木県立がんセンター(栃木県) 防衛医科大学校(埼玉県) 埼玉県立がんセンター(埼玉県) 国立がん研究センター東病院(千葉県) 国立がん研究センター中央病院(東京都) がん・感染症センター都立駒込病院(東京都) 東京医科歯科大学(東京都) がん研究会有明病院(東京都) 虎の門病院(東京都) 都立墨東病院(東京都) 神奈川県立病院機構神奈川県立がんセンター(神奈川県) 北里大学医学部(神奈川県) 横浜市立大学附属市民総合医療センター(神奈川県) 新潟県立がんセンター新潟病院(新潟県) 新潟県厚生連長岡中央綜合病院(新潟県) 燕労災病院(新潟県) 富山県立中央病院(富山県) 石川県立中央病院(石川県) 岐阜大学医学部(岐阜県) 岐阜市民病院(岐阜県) 静岡県立総合病院(静岡県) 静岡県立静岡がんセンター(静岡県) 愛知県がんセンター中央病院(愛知県) 名古屋大学医学部(愛知県) 国立病院機構京都医療センター(京都府) 大阪大学医学部(大阪府) 近畿大学医学部(大阪府) 大阪府立病院機構大阪府立成人病センター(大阪府) 国立病院機構大阪医療センター(大阪府) 大阪医科大学(大阪府) 市立豊中病院(大阪府) 市立堺病院(大阪府) 関西医科大学附属枚方病院(大阪府) 神戸大学医学部(兵庫県) 関西労災病院(兵庫県) 兵庫医科大学(兵庫県) 兵庫県立がんセンター(兵庫県) 市立伊丹病院(兵庫県) 天理よろづ相談所病院(奈良県) 和歌山県立医科大学(和歌山県) 島根大学医学部(島根県) 岡山大学病院(岡山県) 広島市立広島市民病院(広島県) 広島市立安佐市民病院(広島県) 福山市民病院(広島県) 国立病院機構四国がんセンター(愛媛県) 高知医療センター(高知県) 大分大学医学部附属病院(大分県) |
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Date of disclosure of the study information |
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Publication of results | Unpublished |
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Recruitment status | No longer recruiting | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004380 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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