JPRN-jRCTs051180198
Active, not recruiting
Phase 2
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 sissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis. - SOX-D2 study
Sano Takeshi0 sites35 target enrollmentMarch 26, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sano Takeshi
- Enrollment
- 35
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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