Neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy for patients with resectable gastric cancer (CRITICS)

Johan L Dikken, Johanna W van Sandick, H A Maurits Swellengrebel, Pehr A Lind, Hein Putter, Edwin P M Jansen, Henk Boot, Nicole C T van Grieken, Cornelis J H van de Velde, Marcel Verheij, Annemieke Cats, Johan L Dikken, Johanna W van Sandick, H A Maurits Swellengrebel, Pehr A Lind, Hein Putter, Edwin P M Jansen, Henk Boot, Nicole C T van Grieken, Cornelis J H van de Velde, Marcel Verheij, Annemieke Cats

Abstract

Background: Radical surgery is the cornerstone in the treatment of resectable gastric cancer. The Intergroup 0116 and MAGIC trials have shown benefit of postoperative chemoradiation and perioperative chemotherapy, respectively. Since these trials cannot be compared directly, both regimens are evaluated prospectively in the CRITICS trial. This study aims to obtain an improved overall survival for patients treated with preoperative chemotherapy and surgery by incorporating radiotherapy concurrently with chemotherapy postoperatively.

Methods/design: In this phase III multicentre study, patients with resectable gastric cancer are treated with three cycles of preoperative ECC (epirubicin, cisplatin and capecitabine), followed by surgery with adequate lymph node dissection, and then either another three cycles of ECC or concurrent chemoradiation (45 Gy, cisplatin and capecitabine). Surgical, pathological, and radiotherapeutic quality control is performed. The primary endpoint is overall survival, secondary endpoints are disease-free survival (DFS), toxicity, health-related quality of life (HRQL), prediction of response, and recurrence risk assessed by genomic and expression profiling. Accrual for the CRITICS trial is from the Netherlands, Sweden, and Denmark, and more countries are invited to participate.

Conclusion: Results of this study will demonstrate whether the combination of preoperative chemotherapy and postoperative chemoradiotherapy will improve the clinical outcome of the current European standard of perioperative chemotherapy, and will therefore play a key role in the future management of patients with resectable gastric cancer.

Trial registration: clinicaltrials.gov NCT00407186.

Figures

Figure 1
Figure 1
Randomization scheme. R: randomization. ECC: epirubicin, cisplatin, capecitabine.
Figure 2
Figure 2
Lymph node stations as defined by the Japanese Research Society for Gastric Cancer. right cardial nodes 1. left cardial nodes. 2. along the lesser curvature. 3. along the greater curvature. 4. suprapyloric nodes. 5. infrapyloric nodes. 6. along the left gastric artery. 7. along the common hepatic artery. 8. around the celiac axis. 9. at the splenic hilum. 10. along the splenic artery. 11. in the hepatoduodenal ligament. 12. dorsal to the pancreatic head. 13. at the root of the mesentery. 14. in the traverse mesocolon. 15. para-aortic nodes.

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