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)

Who is this study for? Patients with stage IIIB/IV advanced gastric cancer who received radical resection
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• \- 1. Patients who voluntarily provide written informed consent prior to entering into this study 2. Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically 3. Patients who underwent radical resection with wide lymph node dissection. 4. TNM(tumor/lymph node/metastasis) stage of IIIB or IV on post-operative staging.

• 5\. Patients who can be randomized within 6 weeks after surgery

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Min-Hee Ryu, M.D.,Ph.D
miniryu@amc.seoul.kr
+82230105935
Backup
Hyung-Don Kim, M.D.,Ph.D
kimhdmd@amc.seoul.kr
+82230100236
Time Frame
Start Date: 2013-10-02
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 286
Treatments
Active_comparator: capecitabine and oxaliplatin
Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1
Experimental: Docetaxel and capecitabine and oxaliplatin
* Docetaxel 60 mg/m² will be intravenously infused over at least 1 hour on Day 1 every 3 weeks.~* Oxaliplatin 100 mg/m² will be intravenously infused over at least 2 hours on Day 1 every 3 weeks.~* Capecitabine 800 mg/m² will be orally administered twice daily from Day 1 evening to Day 15 morning every 3 weeks. (Total 1,600 mg/m² daily)
Related Therapeutic Areas
Sponsors
Collaborators: Seoul National University Bundang Hospital, Inha University Hospital, Severance Hospital, Hallym University Medical Center
Leads: Asan Medical Center

This content was sourced from clinicaltrials.gov