Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
|Gastric Cancer||Drug: DCS (docetaxel with cisplatin with TS-1) Drug: DCF (docetaxel with cisplatin with 5-FU)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- RECIST(Response Evaluation Criteria in Solid Tumors) [ Time Frame: written in the description part below ]
- 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<Response Evaluation Criteria in Solid Tumor> 1.0 version use)
|Study Start Date:||September 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Active Comparator: DCS
DCS: docetaxel with cisplatin with TS-1
Drug: DCS (docetaxel with cisplatin with TS-1)
Active Comparator: DCF
DCF : docetaxel with cisplatin with 5-FU
Drug: DCF (docetaxel with cisplatin with 5-FU)
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286766
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-750|