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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Stomach Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

S-1 (452500ACH)

Intervention Type DRUG

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

OXALIPLATIN (205803BIJ)

Intervention Type DRUG

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

Interventions

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S-1 (452500ACH)

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

Intervention Type DRUG

OXALIPLATIN (205803BIJ)

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

Intervention Type DRUG

Other Intervention Names

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TS-1 (tegafur+gimeracil+oteracil) PLEOXTIN (645402430)

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No