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

NCT02191566 | Terminated Phase 2

• 1 other identifier: SOHUG
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Stomach Cancer

Keywords

Stomach Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year recurrence-free survival, RFS

  3-year

Secondary Outcomes (1)

• 5-year overall survival, OS

  5-year

Other Outcomes (2)

• Toxicity will be graded according to the CTCAE.

  1-year

• compliance for chemotherapy

  1-year

Study Arms (1)

S-1/Oxaliplatin

EXPERIMENTAL

S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months

Drug: S-1 (452500ACH); Drug: OXALIPLATIN (205803BIJ)

Interventions

S-1 (452500ACH) DRUG

S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months

Also known as: TS-1 (tegafur+gimeracil+oteracil)

S-1/Oxaliplatin

OXALIPLATIN (205803BIJ) DRUG

Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months

Also known as: PLEOXTIN (645402430)

S-1/Oxaliplatin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Related Publications (3)

• 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.

  PMID: 22010012 BACKGROUND

• 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.

  PMID: 22226517 BACKGROUND

• 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.

  PMID: 20734110 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination); titanium silicide; tegafur-gimeracil-oteracil; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Dong Hoe Koo, MD,PhD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Hematology/Oncology, Department of Internal Medicine, Sungkyunkwan University School of Medicine

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: July 16, 2014
• Study Start: May 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

KR (1)