Asan Medical Center
Seoul, 138-736, South Korea
Location status: Recruiting
Location contact
Min-Hee Ryu, M.D., Ph.D.
CONTACT
Park Sook-Ryun, MD,PhD
SUB_INVESTIGATOR
Ryoo Back-Yeol, MD,PhD
SUB_INVESTIGATOR
Ryu Min-Hee, MD,PhD
SUB_INVESTIGATOR
NCT Number: NCT01935778
multicenter, open label, randomaized, phase III
The role of post surgery adjuvant chemotherapy is becoming more and more important in AGC (advance gastric cancer). S-1 and combined therapy of Capecitabine and Oxaliplatin are currently accepted as a standard therapy among the AGC patients who were performed gastrectomy from the D2 surgery. However, many improvements will be needed in stage IIIB and IV. Combined chemotherapy of Docetaxel, Capecitabine, and Oxaliplatin may be considered as one of the best treatments for IIB and IV(M0) stage AGC patients who were performed gastrectomy.
Interested in participating?
Request Info20 year–75 year
All sexes
Interventional
Phase 3
Seoul, 138-736, South Korea
Location status: Recruiting
Min-Hee Ryu, M.D., Ph.D.
CONTACT
Park Sook-Ryun, MD,PhD
SUB_INVESTIGATOR
Ryoo Back-Yeol, MD,PhD
SUB_INVESTIGATOR
Ryu Min-Hee, MD,PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Docetaxel 60 mg/m² IV Day 1 Capecitabine 800 mg/m² bid (Day 1-Day 14) Oxaliplatin 100 mg/m² IV Day 1
Other names: docetaxel/xeloda/oxliplatin
Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1
Time frame: 3 years
To compare 3-year disease-free survival (DFS) between the two groups. DFS is defined as the time from randomization date to objective tumor recurrence as assessed with the RECIST 1.1, onset of new gastric cancer, or death.
Time frame: 6 years
Overall survival (OS): Overall survival is defined as the time from randomization date to date of death by any cause. If death cannot be confirmed, survival time will be the last date when the subject's survival is confirmed or the date when the contact is lost, whichever comes first. For subjects lost to follow-up, the last contact date will be entered.
Time frame: 6 years
Safety evaluation: Type and severity of adverse events will be compared between the two groups.
Contact information is provided by the study sponsor or research team.
Hyung-Don Kim, M.D.,Ph.D
CONTACT
Min-Hee Ryu, M.D.,Ph.D
CONTACT
Asan Medical Center
Other
A Phase 3, Open-Label, Randomized Study to Compare Adjuvant Chemotherapy of Docetaxel/Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin in Advanced Gastric Cancer Patients at Stage IIIB and IV (M0) (Based on AJCC Ed. 6) Who Received Radical Resection(KCSG ST15-08)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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