Phase 3 Study of Lobaplatin,5-Fluorouracil and Leucovorin for the Treatment of Recurrent or Metastatic Esophageal Carcinoma
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
objective response rate(ORR) time to progression (TTP) toxicities
12/31/2010
Yes
Lin Guan
Study Chair
Taian Cancer Hospital
China: Food and Drug Administration
TACH2009001
NCT01034683
December 2009
December 2010
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