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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000027506 |
Receipt No. | R000031497 |
Scientific Title | A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2020/11/30 |
Basic information | ||
Public title | A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis | |
Acronym | A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis | |
Scientific Title | A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis | |
Scientific Title:Acronym | A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis | |
Region |
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Condition | ||||
Condition | Gastric cancer | |||
Classification by specialty |
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Classification by malignancy | Malignancy | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate efficacy and safety of gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis following systemic chemotherapy with S-1 and Oxaliplatin |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Others |
Trial characteristics_2 | Others |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | 3-year overall survival |
Key secondary outcomes | Proportion of R0 resection, 5-year overall survival, 3- and 5-year recurrence free survival, Proportion of completion of surgery, Proportion of completion of protocol treatment, Clinical response rate, Pathological response rate, Adverse events from chemotherapy, Operation time, Intraoperative blood loss, Surgical complications, Postoperative hospital stay |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |||
No. of arms | 1 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Gastrectomy with D2 or D2 plus dissection of para-aortic lymph nodes diagnosed as metastases at initial diagnosis is performed after three or four 21-day cycles of S-1 plus oxaliplatin. S-1 is also given for 1 year after gastrectomy. | ||
Interventions/Control_2 | |||
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 | 1) Histologically proven gastric adenocarcinoma
2) HER2 negative (IHC 0 or IHC 1+, or IHC 2+/FISH -) 3) One of the following conditions is fulfilled by enhanced CT 1. Paraaortic lymph node metastasis (No.16a2/ 16b1) 2. Bulky N (at least one node of 3 cm or more in diameter, or at least three consecutive nodes each of diameter 1.5 cm or more, along the coeliac, splenic, common or proper hepatic arteries or superior mesenteric vein.) 3. Both of No.16a2/ 16b1 and bulky lymph node metastasis 4. Thoracic/ abdominal/ pelvic enhanced CT reveals none of the following findings: i) Mediastinal lymph node metastasis ii) Lung metastasis iii) Peritoneal metastasis iv) Liver metastasis v) Pleural effusion, ascites beyond the pelvis vi) Paraaortic No. 16a1 or No. 16b2 swelling 1cm or greater vii) Other distant metastases (except for No. 13, No. 16a2 or No. 16b1 metastasis) 5) Neither Borrmann type 4 nor large (8cm or more) type 3 6) Length of esophageal invasion less than or equal to 3cm 7) Not stump cancer of stomach. 8) Clinically no sign of distant metastasis 9) No liver or peritoneal metastasis and CY0 by laparoscopy or laparotomy for bypass surgery within 28 days before registration 10) Age between 20 and 75 at registration 11) Performance Status (ECOG) 0 or 1 12) No prior chemotherapy, radiotherapy or endocrinotherapy 13) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic mucosal resection 14) Fair oral intake with or without bypass surgery 15) Adequate organ functions defined as indicated below; i) WBC >= 4,000/mm3 and <= 12,000/mm3 ii) Neutrophils >= 4,000/mm3 iii) Hb >= 8.0 g/dl iv) Platelet >= 100,000/mm3 v) AST <= 100IU vi) ALT <= 100IU vii) T.bil <= 1.5 mg/dL viii) Creatinine <= 1.2 mg/dL viii) Ccr >= 60 mL/min/body 16) Written informed consent |
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Key exclusion criteria | 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal cancer
2) Women during pregnancy or breast-feeding 3) Severe mental disease 4) Under treatment with systemic steroid 5) HBs antigen positive 6) Under treatment with flucytosine, phenytoin, or warfarin 7) Allergy to iodine 8) History of hypersensitivity to oxaliplatin or S-1 9) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason 10) Edema of limbs or trunk by any reason 11) Interstitial pneumonia, pulmonary fibrosis or severe emphysema. 12) Active bacterial or fungal infection 13) Past history of myocardial infarction or unstable angina pectoris within 6 months 14) Uncontrollable hypertension 15) Uncontrollable diabetes mellitus or routine administration of insulin |
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Target sample size | 35 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Cancer Institute Hospital | ||||||
Division name | Division of gastroenterological surgery | ||||||
Zip code | |||||||
Address | 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan | ||||||
TEL | 03-3520-0111 | ||||||
takeshi.sano@jfcr.or.jp |
Public contact | |||||||
Name of contact person |
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Organization | Cancer Institute Hospital | ||||||
Division name | Division of gastroenterological surgery | ||||||
Zip code | |||||||
Address | 3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan | ||||||
TEL | 03-3520-0111 | ||||||
Homepage URL | |||||||
koshi.kumagai@jfcr.or.jp |
Sponsor | |
Institute | Cancer Institute Hospital |
Institute | |
Department |
Funding Source | |
Organization | Self-sustaining fund |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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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 | がん研究会有明病院(東京都)
国立がん研究センター中央病院(東京都) 静岡県立静岡がんセンター(静岡県) 国立がん研究センター東病院(千葉県) 愛知県がんセンター中央病院(愛知県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
Registered date |
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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=R000031497 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |