CapeOX Study

JRCT ID: jRCTs051180126

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 23/09/2016
• Target sample size: 110
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, Time to treatment failure, Response rate, Relative dose-intensity, Frequency of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yamaguchi Kensei
• Secondary Sponsor: Yakult Honsha
• Secondary ID(s): UMIN000022450