Metastatic Advanced Gastric Cancer
Conditions
Keywords
AGC, second-line, docetaxel, epirubicin
Brief summary
A salvage treatment with combination of docetaxel and epirubicin in patients with unresectable, metastatic gastric cancer after fluoropyrimidine failure : A HER2 status-based study
Interventions
OTHERDocetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks
Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.
Sponsors
Yonsei University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed metastatic, or recurrent AGC 2. Previous use of fluoropyrimidine as palliative chemotherapy. Concurrent use of platinum is permitted. Patient with recurred disease within 6 months after the end of adjuvant therapy can participate to this trial. 3. Documented HER2 expression status. 4. Radiologically proven progression of disease. 5. Age \> 20 years 6. ECOG PS 0 - 2 7. Life expectancy more than 3 months 8. Adequate organ function for treatment including liver, kidney and bone marrow (absolute neutrophil count (ANC) ≥ 1,500/ul, platelets ≥ 100,000/ul, AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if liver involvement, Total serum bilirubin ≤ 2.0 mg/dL) 9. Written informed consent
Exclusion criteria
1. Prior administration of taxane or anthracycline as palliative chemotherapy. If those agents were used as adjuvant or neoadjuvant aim, at least 6 months should be passed. 2. Uncontrolled medical comorbidities Congestive heart failure (NYHA class III or IV) Recent (within 6 months) unstable angina or myocardial infarct Clinically significant cardiac arrhythmia LVEF \< 45% Liver cirrhosis (Child-Pugh class B or C) Interstitial pneumonia Psychiatric illness/social situations that would limit compliance with study requirements 3. Active CNS metastasis not controllable with radiation or steroid 4. Concurrent administration of systemic chemotherapy or radiotherapy. Palliative radiotherapy for pain control more than 2 weeks ago is acceptable. 5. Pregnant or lactating women. 6. Peripheral neuropathy G3\ 4. 7. Metachronous malignancy other than adequately treated CIN of uterine cervix, basal cell or squamous cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate according to the RECIST v1.1 | at 6~8 weeks later after the first evaluation | The primary outcome of the current study is the disease control according to the HER2 status. That is, the % of the patients who maintains at least stable disease by RECIST v1.1 at the time of the second tumor evaluation which will be taken at 6\ 8 weeks later after the first evaluation. The comparison will be done by Pearsons's chi-square test. |
Countries
South Korea
Outcome results
None listed