A Randomized Phase II Trial of Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
Treatment scheme
- Screening period: D-21 to D1 (treatment day)
- Preoperative screening includes EUS, laparoscopy (optional), EGD and abd-pelvic CT
scan.
- Preoperative clinical staging is based on the guideline of Japanese Gastric Cancer
Association (JGCA, 1998)
- Tumor response is assessed every 2 cycles (6 weeks)
- Treatment is repeated until,.
- 4 cycles
- progressive disease
- unacceptable toxicity
- patient's withdrawal
- Gastric surgery should be performed within 4~6 weeks of the last dose of chemotherapy
- Gastric surgery is for curative aim and should include ≥ D2 LN dissection.
- Patients who received R0 resection should receive at least 4-cycled adjuvant
chemotherapy with 5-FU and cisplatin.
- Palliative chemotherapy should be indicated for inoperable progressive disease or who
failed curative resection. 5-FU and oxaliplatin combination is recommended as
first-line therapy.
- Follow up for survival is repeated every 3 months for 2 years
Study period Patient enroll period for 12 months., and follow-up duration for further 12
months., resulting total study period of 24 months
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
RECIST(Response Evaluation Criteria in Solid Tumors)
safety : every cycle adverse event/serious adversr event evaluation from NCI-CTC(version 3.0)
efficacy : tumor response is assessed every 2 cycles (6weeks) -> tumor response assessment(RECIST
written in the description part below
No
South Korea: Korea Food and Drug Administration (KFDA)
4-2009-0332
NCT01286766
September 2009
August 2013
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