Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC
Recruitment status was Recruiting
To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer|
- response rate
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||July 2009|
Active Comparator: 1
Docetaxel 35 mg/m2 will be administered on days 1 and 8. Cisplatin 60 mg/m2 will be administered on day 1 every 3 weeks.
Cisplatin 60 mg/m2 will be given on day 1.
Docetaxel 35 mg/m2 will be administered on days 1 and 8. Oxaliplatin 120 mg/m2 will be administered on day 1 every 3 weeks.
oxaliplatin 120 mg/m2 will be given on day 1.
Other Name: Eloxatin
Gastric cancer is the most frequently occurring malignancy in Korea, and is one of the main causes of cancer death. While treatment options for AGC have expanded in recent years to include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a problem. Recently, weekly schedule of docetaxel is appealing due to limited incidence of severe myelosuppression compared with standard 3-weekly regimen. This altered toxicity profile suggests a potential for better tolerance and increased dose intensity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510107
|Contact: Dong Bok Shin, MD, PhD||82 32 460 firstname.lastname@example.org|
|Korea, Republic of|
|Gachon University Gil Medical Center||Recruiting|
|Incheon, Korea, Republic of, 405 760|
|Principal Investigator:||Se Hoon Park, MD||Gachon University Gil Medical Center, Incheon, Korea|