Esophagus Disorders Clinical Trial
Official title:
Perioperative Versus Preoperative Chemotherapy With Surgery in Patients With Locoregional Squamous Carcinoma of Esophagus
To assess whether or not a perioperative therapy with surgery can improve the outcomes among patients with potentially curable squamous carcinoma of esophagus as compared to a preoperative chemotherapy followed by surgery
Perioperative chemotherapy has been shown to significantly improve the R0 resection rate, the
disease free survival and the overall survival in patients with adenocarcinoma of the
esophagus, the gastroesophageal junction and the stomach. Therefore, perioperative
chemotherapy is the new therapeutic standard (Cunningham NEJM 2006, MRC, Lancet 2002, Boige
ASCO 2007). The best-evaluated regime is the combination of Epirubicin, Cisplatin and 5-FU
(ECF) (Cunningham, NEJM 2007). Cisplatin and 5-FU are considered to be the most important
components to form the cornerstone of this regime.
Paclitaxel is a new and highly active cytotoxic agent. In a randomized phase II study, the
dual combination of Paclitaxel and 5-FU seemed to show similar effects as ECF, administered
as first line treatment. The triplet combination of Paclitaxel, Cisplatin and 5-FU has
significantly superior efficacy than a combination of Cisplatin und 5-FU (Van Cutsem, JCO
2007).
It has been shown that Capecitabine is more active than 5-FU and can replace intravenous 5-FU
in the combination with Cisplatin in the treatment of esophageal cancer. Capecitabine
therefore is FDA approved for esophageal cancer (Cunningham, ASCO 2006, Kang ASCO 2006).It
seems reasonable to optimize perioperative chemotherapy by including this modern
chemotherapeutics.
In this study, patients with squamous carcinoma of esophagus and gastroesophageal junction
who seem operable with curative intent according to oncological and surgical assessment are
treated with 2 preoperative cycles of PCF followed by surgical resection, followed by 2
postoperative cycles of PCF. Among patients with no responses to preoperative chemotherapy,
Capecitabine 625 mg/m² twice-daily dose is defined as alternatives to infused 5-Fluorouracil
in the postoperative chemotherapy regimen Postoperative chemotherapy will start within 4-6
weeks after the operation. 3 weeks after the end of the last chemotherapy the final
investigation (end of study visit) will be done.
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