Status:
UNKNOWN
Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer
Lead Sponsor:
The Catholic University of Korea
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination thera...
Detailed Description
Study rationale : Park et al. observed the oxaliplatin as part of XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profil...
Eligibility Criteria
Inclusion
- Histologically proven gastric cancer
- Minimum age of 18 years
- Stage IV (regardless of the presence or absence of measurable disease by RECIST criteria) or recurrent after curative surgery
- Negative expression (0, 1) of Her2 Immuno-histochemistry or negative amplification of FISH in Her2 Immuno-histochemistry 2+
- More than stable disease after 6 cycle 1st line of XELOX chemotherapy (OR non-Complete response/non-Progressive disease in cases of non-measurable disease before XELOX chemotherapy)
- Eastern Cooperative Oncology Group Performance status 0-2
- Adequate bone marrow function: Absolute neutrophil count ≥ 1,500/ul, Hemoglobin ≥ 8 g/dL, platelet ≥ 100,000/μl
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN (upper normal limit) or creatinine clearance ≥ 60 ml/min
- Adequate hepatic function: serum bilirubin ≤ 2.5 x UNL, AST and ALT ≤ 2.5 x UNL (≤ 5 x ULN in the presence of liver metastasis)
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
Exclusion
- Patients who were exposed previously to any chemotherapy except XELOX for advanced disease
- Patients who received R0 or R1 resection for metastatic or recurrent gastric cancer and without evaluable/measurable disease
- Disease relapsed during or within 4 months after adjuvant therapy
- Patients who had central nervous system and meningeal metastases
- Patients with significant neurologic or psychiatric disorders
- Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
- Any previous or concurrent malignancy except for adequately treated non-melanoma skin cancer, in situ cancer of uterine cervix, non-muscle invasive bladder cancer or malignancy without evidence of recurrence within 5 years
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT02289547
Start Date
May 1 2015
End Date
January 1 2019
Last Update
June 14 2017
Active Locations (8)
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1
St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 442-723
2
Buchon St. Mary's Hospital
Buchon, South Korea
3
Daejeon St. Mary's Hospital
Daejeon, South Korea
4
Incheon St. Mary's Hospital
Incheon, South Korea