squamou cell carcinoma of esophagus
Conditions
Interventions
gemcitabine / oxaliplatin:gemcitabine + oxaliplatin
control:5-fluorouracil + cisplatin
Sponsors
Westchina hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed diagnosis of Stage IV squamous cell esophageal carcinoma or who have distant relapse with or without adjuvant chemotherapy after dissection(the gap from the last cycle of adjuvant chemotherapy to distant relapse are more than 6 months); 2. Clinical benefit (disease stabilization or antitumour response) of at least 12 weeks duration on chemotherapy with GP or PF; 3. Male and female patients age less than18 years; 4. Eastern Cooperative Oncology Group (ECOG, performance Score 0-1; 5. Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as =10 mm but no less than double the slice thickness according to RESIST 1.1 (R09-0262); 6. Male and female patients age =18 years; 7. Life expectancy of at least 12 weeks; 8. Written informed consent that is consistent with ICH-GCP guidelines.
Exclusion criteria
Exclusion criteria: 1) Patients with stage IV disease have received chemotherapy; 2) Chemotherapy within the past 6 months after dissection; 3) Received surgerysample or surgery within 7 days; 4) Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohns disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline; 5) Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug; 6) Other malignancies diagnosed (other than non-melanomatous skin cancer and in situ cervical cancer) requiring therapy; 7) Radiotherapy within the past 2 weeks prior to treatment the target lesion; 8) History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) functional classification of 3, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization; 9) Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram; 10) Absolute neutrophil count (ANC) =1.5 mg/dL (>26 µmol/L, SI unit equivalent); 13) Aspartate amino transferase (AST) or alanine amino transferase (ALT) >=1.5 times the upper limit of normal (if related to liver metastases >=five times the upper limit of normal); 14) Serum creatinine >=1.5 times the upper normal limit or calculated/measured creatinine clearance <=45 mL/min; 15) Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial; 16) Pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to tumor progress;Objective response;Clinical benefit rate;media survival; | — |
Countries
China
Contacts
Public ContactYou Lu
Westchina hospital, Sichuan University
Outcome results
None listed