Stomach Cancer
Conditions
Keywords
Stomach Cancer
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).
Interventions
DRUGS-1 (452500ACH)
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months
DRUGOXALIPLATIN (205803BIJ)
Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year recurrence-free survival, RFS | 3-year |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival, OS | 5-year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Toxicity will be graded according to the CTCAE. | 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. |
| compliance for chemotherapy | 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. |
Countries
South Korea
Outcome results
None listed