Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma
This trial is active, not recruiting.
|Treatment||lobaplatin , 5-fu ,leucovorin|
|Sponsor||Taian Cancer Hospital|
|Start date||December 2009|
|End date||December 2010|
|Trial size||120 participants|
|Trial identifier||NCT01034683, TACH2009001|
The purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin, 5-fluorouracil (5-FU) and leucovorin in patients with esophageal carcinoma.
|Intervention model||single group assignment|
objective response rate(ORR) time to progression (TTP) toxicities
time frame: 12/31/2010
1-year survival rate KPS score
time frame: 12/31/2009
Male or female participants from 18 years up to 65 years old.
- Histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer)
- Newly diagnosed patients should be unable or unwilling to surgery
- Recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed
- Patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(CT)and measurements of maximum diameter≥1cm.
- Cooperative Oncology Group performance status 0-2 or KPS score ≥60,survival time ≥3 months
- Neutrophils(ANC)≥1.5×109/L; blood platelets counts(BPC)≥80×109/L
- Hemoglobin(Hgb)≥90g/L ,serum total bilirubin ≤1.0 times the upper normal limit(ULN): alanine aminotransferase and glutamic-oxalacetic transaminase (ALT and AST)≤2.5 ULN
- Serum creatinine (Cr)≤1.5ULN
- pregnant or nursing women;
- Female patients at child-bearing age, without taking effective contraceptive methods;
- patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer;
- patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment;
- patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,NCIC-CTG standard >grade 2
- patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose> 7.8mmol / L
|Official title||Phase 3 Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma|
|Description||patients with metastatic or recurrent esophageal cancer have a particularly poor prognosis .The overall 5-year survival rate for patients with newly diagnosed esophageal cancer is under 10%. Metastatic esophageal carcinoma is an incurable disease and due to the lack of effective therapies to manage this disease,the median survival is only 6 to 8 months Chemotherapy which is one of the most effective treatment so far is used as part of combined modality therapy for locally advanced diseases or as a palliative treatment for metastatic diseases.Lobaplatin is the third generation of platinum.Phase Ⅱclinical trials indicate that lobaplatin is effective for esophageal cancer, ovarian cancer, breast cancer and small cell lung cancer.|
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