Combination Treatment of S-1 With Paclitaxel in Advanced Esophageal Cancer
Status:
Terminated
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
Esophageal cancer is one of the common malignant disease, especially in China. The annual
incidence of esophageal squamous cell carcinoma is 260,000 with the motility of 210,000. The
prognosis of esophageal cancer is very poor. About 50% of patients have advanced disease at
diagnosis and the natural course is only 6-8 months with a 5-year survival rate of 5-7%.
Though some patients received surgical treatment, disease will recurrent and metastasis in
nearly 90% of the patients.
In past decades, there isn't much improvement of the outcome and survival of advanced
esophageal cancer due to the lack of effective chemotherapy agents. The traditional
chemotherapy drugs include 5-fluorouracil and cisplatin and the combination of them results
in a 25-35% response rate in both first-line and palliative treatment. Paclitaxel plus
cisplatin regiment is another promising treatment of esophageal cancer and have been proved
effective in many studies. One of our previous study showed paclitaxel and cisplatin
treatment resulted in encouraging response rate with manageable side-effects in 131 patients
of advanced esophageal cancer.
However, the toxicities of paclitaxel and cisplatin limit their combination in clinic. For
example, the polyoxyethylene castor oil paclitaxel could induce acute hypersensitivity
reactions and neurotoxicity. Cisplatin could result in dysfunction of kidney and
neurotoxicity. In addition, most of esophageal cancer patients are age 65 to 70. Many of them
have simultaneously other diseases such as hypertension, diabetes, and chronic kidney disease
which cause varying damages of renal function and limit the use of cisplatin in these
patients. Therefore, it is urgent for doctors to seek an alternative of cisplatin in the
combination chemotherapy treatment.
Therefore, the investigators designed this randomized clinical trial in which a novel
combination of S-1 with paclitaxel is used to treat advanced esophageal cancer patients in
compare with paclitaxel/cisplatin and 5-FU/cisplatin treatment to explore its efficacy and
toxicity. The investigators hope this study will provide some clues for the treatment of
esophageal cancer patients.