Randomized Phase III Trial of Adjuvant Chemotherapy or Chemoradiotherapy in Resectable Gastric Cancer (CRITICS)
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|ClinicalTrials.gov Identifier: NCT00407186|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2006
Last Update Posted : October 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: cisplatin+capecitabine Radiation: radiotherapy Drug: epirubicin+cisplatin+capecitabine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||788 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||January 11, 2007|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2025|
5 weeksadjuvant treatment; radiotherapy and concomitant chemotherapy with cisplatin and capecitabine.
cisplatin 20 mg/m2 (i.v., q 1 w, 5 weeks), capecitabine 575 mg/m2 (b.i.d., oral, on radiotherapy days.
45 Gy in 25 fracions (5 days/week)
Active Comparator: 2chemotherapy
3 adjuvant courses epirubicin, cisplatin, capecitabine.
3 courses q 3 w: epirubicin 50 mg/m2 (i.v., day 1), cisplatin 60 mg/m2 (i.v., day 1), capecitabine 1000 mg/m2 (b.i.d., oral, day 1-14)
- overall survival [ Time Frame: study duration ]
- disease-free survival [ Time Frame: study duration ]
- toxicity [ Time Frame: study duration ]
- health-related quality of life [ Time Frame: study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407186
|Nederlands Kanker Instituut/Antoni van Leeuwenhoek Ziekenhuis|
|Amsterdam, Netherlands, 1066 CX|
|Principal Investigator:||Marcel Verheij, MD PhD||Nederlands Kanker Insituut/Antoni van Leeuwenhoek Ziekenhuis|