JRCT ID: jRCTs051180198
Registered date:26/03/2019
SOX-D2 study
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Gastric Cancer |
Date of first enrollment | 02/05/2018 |
Target sample size | 35 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | 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. |
Outcome(s)
Primary Outcome | 3-year overall survival |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 75age old |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Sano Takeshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000027506 |
Contact
Public contact | |
Name | Rie Makuuchi |
Address | 3-8-31, Ariake, Koto-ku, Tokyo Tokyo Japan 135-8550 |
Telephone | +81-3-3520-0111 |
rie.makuuchi@jfcr.or.jp | |
Affiliation | The Cancer Institute Hospital of JFCR |
Scientific contact | |
Name | Takeshi Sano |
Address | 3-8-31 Ariake, Koto-ku, Tokyo Tokyo Japan 135-8550 |
Telephone | +81-3-3520-0111 |
takeshi.sano@jfcr.or.jp | |
Affiliation | The Cancer Institute Hospital of JFCR |