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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)

SOX-D2 study (SOX-D2 study)

Nunobe Souya

The Cancer Institute Hospital of JFCR

3-8-31 Ariake, Koto-ku, Tokyo

souya.nunobe@jfcr.or.jp

Hayami Masaru

The Cancer Institute Hospital of JFCR

3-8-31, Ariake, Koto-ku, Tokyo

+81-3-3520-0111

masaru.hayami@jfcr.or.jp

Not Recruiting

Sept. 28, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

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

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

Both

Gastric Cancer

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.

3-year overall survival

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

+81-73-441-0714

Feb. 21, 2019

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