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)
Overview
- Phase
- Phase 3
- Intervention
- capecitabine and oxaliplatin
- Conditions
- Gastric Cancer, Adjuvant Chemotherapy, XO
- Sponsor
- Asan Medical Center
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- disease-free survival
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Min-Hee Ryu
Professor
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients who voluntarily provide written informed consent prior to entering into this study
- •Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
- •Patients who underwent radical resection with wide lymph node dissection.
- •TNM(tumor/lymph node/metastasis) stage of IIIB or IV on post-operative staging.
- •Patients who can be randomized within 6 weeks after surgery
Exclusion Criteria
- •Aged \< 20 years or ≥ 76 years
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥2
- •Patients who underwent surgery for neoplasm in stomach in the past
- •History of malignant disease The following cases can be included in this study.
- •Adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
- •Other cancer for which more than 5 years have passed since chemotherapy was completed and disease-free status has been maintained for 5 years or more
- •Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
- •Residual cancer on post-operative staging (R1 and R2 resection)
- •Patients who received alleviator, adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
- •Patients who participated in another clinical trial or received another investigational product within 30 days prior to providing informed consent
Arms & Interventions
capecitabine and oxaliplatin
Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1
Intervention: capecitabine and oxaliplatin
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)
Intervention: Docetaxel and capecitabine and oxaliplatin
Outcomes
Primary Outcomes
disease-free survival
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.
Secondary Outcomes
- overall survival(6 years)
- safety profile(6 years)