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

December 6, 2022 updated by: Dong-Hoe Koo, Kangbuk Samsung Hospital

A Phase II Study of Adjuvant Chemotherapy of S-1 With Oxaliplatin in Gastric Cancer at Stage IIIB/ IV (AJCC 6th) After D2 Resection

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-1/Oxaliplatin
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)
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months
Other Names:
  • TS-1 (tegafur+gimeracil+oteracil)
Drug: OXALIPLATIN (205803BIJ)
Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
Other Names:
  • PLEOXTIN (645402430)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-year recurrence-free survival, RFS
Time Frame: 3-year
3-year

Secondary Outcome Measures

Outcome Measure
Time Frame
5-year overall survival, OS
Time Frame: 5-year
5-year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity will be graded according to the CTCAE.
Time Frame: 1-year
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
compliance for chemotherapy
Time Frame: 1-year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Investigators

  • Principal Investigator: Dong Hoe Koo, MD,PhD, Kangbuk Samsung Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOHUG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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