Untreated metastatic gastric cancer
Conditions
Interventions
CapeOX (oxaliplatin
100 mg/m2 [day 1], capecitabine
1,500 mg/m2/day [day1-day15]): The treatment will be repeated every 3 weeks, unless the disease progression, unacceptable toxicity, tumor resection, or consent withdrawal
Sponsors
The Tokyo Cooperative Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric adenocarcinoma, signet-ring cell, mucinous, or hepatoid 2) HER2 negative or unknown 3) Metastatic 4) Adequate oral intake 5) Evaluable leision by RECIST Ver.1.1 6) Surgical history: Interval over 4w from abdominal surgery, over 2w from palliative surgery or non-curative resection 7) No prior treatment of chemotherapy, radiation therapy, or immunotherapy: excluding recurrence at least 6 months after completion of post-operative adjuvant chemotherapy not containing oxliplatin 8) Aged 70 years and over 9) Performance Status(ECOG) 0 or 1 10) Patients who are expected to survive more than 3 months 11) Adequate organ function: i) Hb>= 8.0 g/dL ii) WBC<= 12,000/mm3 iii) Neutrophil>= 1,500/mm3 iv) Platelet>= 100,000/mm3 v) Total bilirubin<= 1.5 mg/dL vi) AST<= 100 IU/L (within less than 5 times of UNL in patients with liver metastasis) vii) ALT<= 100 IU/L (within less than 5 times of UNL in patients with liver metastasis) viii) Serum creatinine<= 1.50mg/dL ix) Ccr>= 50 mL/min 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Blood transfusion, blood products or G-CSF within 21 days at registration 2) Peripheral sensory neuropathy: Grade 1 or greater 3) Uncontrolled hypertension or diabetes; interstitial pneumonia, pulmonary fibrosis, or severe emphysema; renal failure, hepatic failure, active gastrointestinal bleeding, stroke in 3 months 4) Abnormal electrocardiogram 5) More than moderate dose of ascites, massive pleural effusion 6) Brain metastasis 7) Extensive bone metastasis 8) Multiple primary cancers 9) HBs antigen positive, HCV or HIV antibody positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Time to treatment failure Response rate Relative dose intensity Incidence of adverse events Geriatric Assessment | — |
Countries
Japan
Contacts
Public ContactHitoshi Masuda
The Tokyo Cooperative Oncology Group CapeOX affairs office
Outcome results
None listed