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 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
study duration
No
Marcel Verheij, MD PhD
Principal Investigator
Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
CRITICS
NCT00407186
December 2006
December 2013
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