S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy

Stomach Cancer Clinical Trial

— SOHUG  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02191566
• Other study ID #: SOHUG
• Status: Terminated
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: October 2019

Study information

• Verified date: December 2022
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1 (452500ACH)
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months
• OXALIPLATIN (205803BIJ)
Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Toxicity will be graded according to the CTCAE.	For patients who have experienced a dosing delay for starting treatment cycle, all assessments will be performed as scheduled. Reasons for dose modifications or delays, the supportive measures taken, and the outcome will be documented in the patient's chart and recorded in the CRF.	1-year
Other	compliance for chemotherapy	Accountability and subject compliance will be assessed by maintaining adequate dose of S1 and return records. Subjects will be asked to return all used and unused drug supply containers at the end of each cycle as a measure of compliance. The clinical administration records will be used to monitor compliance with oxaliplatin.	1-year
Primary	3-year recurrence-free survival, RFS		3-year
Secondary	5-year overall survival, OS		5-year