Gastric Cancer Clinical Trial
Official title:
A Multicenter Randomized Phase III Trial of Neo-adjuvant Chemotherapy Followed by Surgery and Chemotherapy or by Surgery and Chemoradiotherapy in Resectable Gastric Cancer (CRITICS Study)
The purpose of this study is to evaluate the efficacy and safety of combined chemotherapy and radiotherapy (in comparison to chemotherapy alone) as adjuvant treatment after surgery for gastric cancer. Prior to surgery all patients will receive neo-adjuvant chemotherapy as well.
The mainstay of curative treatment of gastric cancer is radical surgical dissection. Because
most patients in the Western world present with advanced stages long term survival is found
in about 25%, with local recurrences as part of treatment failure in up to 80% of cases.
Studies examining the role of more extended lymph node dissections (D1 vs. D2), adjuvant
radiotherapy or adjuvant chemotherapy did not result in a clinical relevant improvement of
survival. In 2001 results of a South West Oncology group (SWOG) trial that randomized between
surgery and surgery with chemoradiotherapy were published. This trial, that was hampered by
suboptimal surgery (less than D1 in majority of patients) and radiotherapy (2D radiotherapy;
35% protocol deviations) showed an absolute increase in median survival of 9 months. More
recently results of the MAGIC study, which randomized between surgery and surgery plus 6
perioperative courses of ECF chemotherapy, were presented. This regimen resulted in an
absolute 5-year survival benefit of 13% and in a 10% higher resectability rate.
This phase III prospectively randomized study investigates whether chemoradiotherapy (45 Gy
in 5 weeks with daily cisplatin and capecitabine) after preoperative chemotherapy (3x ECC
(epirubicin, cisplatin, capecitabine)) and adequate (D1+) surgery leads to improved survival
in comparison with postoperative chemotherapy (3x ECC). Furthermore, toxicity of both
treatment regimens will be explored.
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