Neoadjuvant Combination Chemotherapy of DCS (Cisplatin + Docetaxel + S-1) and DCF (Docetaxel + Cisplatin + 5-FU) in Patients With Locally Advanced Gastric Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT01286766|
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : March 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: DCS (docetaxel with cisplatin with TS-1) Drug: DCF (docetaxel with cisplatin with 5-FU)||Phase 2|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286766
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-750|