Description:

Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01034683

Link:

https://clinicaltrials.gov/show/NCT01034683

Keywords:
Versions (1) ▾
  1. 12/13/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

December 13, 2019

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License:
Creative Commons BY 4.0
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Eligibility Esophageal Carcinoma NCT01034683

Eligibility Esophageal Carcinoma NCT01034683

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