A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)
20 Years
N/A
Both
Gastric Adenocarcinoma
Trial Information
A Randomized, Multicenter, Open-label, Phase III Trial of Docetaxel and S1 (DS) Versus S1 and Cisplatin (SP) in Curatively Resected (D2) Gastric Cancer of Stage IIIB/IV (M0)
Inclusion Criteria:
- Histologically proven, Stage IIIb/ IIIc curatively resected gastric carcinoma
- ECOG performance status 0-1
- Curatively resected advanced gastric cancer patients of stage IIIb/IIIc
- D2 lymph node dissection with R0 surgery
- Signed informed consent
Exclusion Criteria:
- Subjects with documented distant metastasis.
- Malabsorption syndrome or disease significantly affecting gastrointestinal function
- Patients with other uncontrolled systemic illness, e.g. infection, poorly controlled
HTN
- History of other malignancy. Subjects who have been disease-free for 5 years or
subjects with successfully treated in situ carcinoma are eligible.
- Subjects with preoperative/adjuvant other cancer treatment, such as chemotherapy,
immunotherapy and radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3-year disease free survival(DFS)
Outcome Description:
Tumor assessments with chest X-rays and CT or MRI scan will be done at 6 months after randomization (after the end of the treatment period), then every 3 months for the first 2 years after randomization and then every 6 months for coming 3 years then one year basis until completion of the study.
Outcome Time Frame:
3 years
Safety Issue:
No
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
4-2009-0708
NCT ID:
NCT01283217
Start Date:
March 2010
Completion Date:
March 2016
Related Keywords:
- Gastric Adenocarcinoma
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Stomach Neoplasms
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