Clinical trial NCT02191566: S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy
Official title: A Phase II Study of Adjuvant Chemotherapy of S-1 With Oxaliplatin in Gastric Cancer at Stage IIIB/ IV (AJCC 6th) After D2 Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stomach Cancer
Keywords: Stomach Cancer
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).


Eligibility criteria: Inclusion Criteria:

* Patients who voluntarily provide written informed consent prior to entering into this study
* Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
* Patients who underwent radical resection with wide lymph node dissection
* TNM stage (6th AJCC) of IIIB or IV on post-operative staging
* Patients who can be randomized within 6 weeks after surgery

Exclusion Criteria:

* Aged \< 20 years or ≥ 76 years
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Patients who underwent surgery for neoplasm in stomach in the past
* History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
* Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
* Residual cancer on post-operative staging (R1 and R2 resection)
* Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
* Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment
* Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment
* Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
* History of hypersensitivity to the investigational products (S1 and Oxaliplatin)

Primary outcomes:
measure: 3-year recurrence-free survival, RFS
timeFrame: 3-year
Secondary outcomes:
measure: 5-year overall survival, OS
timeFrame: 5-year
Other outcomes:
measure: Toxicity will be graded according to the CTCAE.
timeFrame: 1-year
measure: compliance for chemotherapy
timeFrame: 1-year
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Dong Hoe Koo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, Nashimoto A, Fujii M, Nakajima T, Ohashi Y. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011 Nov 20;29(33):4387-93. doi: 10.1200/JCO.2011.36.5908. Epub 2011 Oct 17.
citation: Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
citation: Lee SS, Jeung HC, Chung HC, Noh SH, Hyung WJ, Ahn JY, Rha SY. A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer. Invest New Drugs. 2012 Feb;30(1):357-63. doi: 10.1007/s10637-010-9515-2. Epub 2010 Aug 24.