Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taian Cancer Hospital
• Treatments: Fluorouracil; Leucovorin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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