Esophageal Cancer
Conditions
Brief summary
There are no standard chemotherapy regimens for metastatic esophageal cancer. Cisplatin plus 5-fluorouracil is widely used as first-line treatment with a response rate ranged from 30% to 40%. Combination of paclitaxel and cisplatin has been investigated in small size clinical trial, producing promising outcome.Liposome capsuled paclitaxel has been proved to be as effective as paclitaxel.The usefulness of the the regimen of paclitaxel liposome with cisplatin is evaluated by median survival time, progression free survival,and response rate.
Interventions
Sponsors
Shantou University Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed metastatic esophageal tumors with no previous treatment for advanced disease or recurrent disease after previous treatment for at least one year. * At least one measurable lesion according to the RECIST1.1 (Response Evaluation Criteria in Solid Tumors RECIST Version 1.1) criteria. Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques. * Patients aged between 18 and 70 years, inclusive, at the time of acquisition of informed consent * Patients with performance status(ECOG) 0 to 1. * Abnormal hematologic values (WBC ≥ 3.0 x 109/L, Hemoglobin ≥ 10.0g/dl, platelet count ≥ 100 x 109/L) * Creatinine clearance ≥ 60 ml/min, Serum creatinine ≤ 1.5mg/dl * Serum bilirubin ≤ 1.5mg/dl. ALT(Alanine transaminase ), AST(Aspartate Transaminase) ≤ 2.5 x upper normal limit (or ≤ 2.5 x upper normal limit in the case of liver metastases) * Life expectancy ≥ 3 months * Patients who have given written informed consent to participate in this study
Exclusion criteria
* Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) * Serious, uncontrolled, concurrent infection(s) or illness(es) * Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia) * Patients with brain metastasis * Patients receiving continuous administration of steroids * Patients who have experienced serious drug allergy in the past * Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment * Patients who are pregnant and lactating or hope to become pregnant during the study period * Patients with prior Taxane treatment (Paclitaxel) * Others, patients judged by the investigator or coinvestigator to be inappropriate as subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median overall survival | one year |
Secondary
| Measure | Time frame |
|---|---|
| median progression free survival | 6 months |
Other
| Measure | Time frame |
|---|---|
| time to progression | 6 months |
Countries
China
Outcome results
None listed