Evidence based radiation therapy for locally advanced resectable and unresectable gastric cancer

Table 3 Ongoing phase III trials for resectable gastric cancer

Study	Sponsor	Estimated Enrollment	Arms	Primary endpoint
Adjuvant chemotherapy or chemoradiotherapy in resectable gastric cancer (CRITICS)	Dutch colorectal cancer group	788	1 CRT(Experimental): cisplatin 20 mg/m2 (IV, q 1 w, 5 wk), capecitabine 575 mg/m2 (bid, oral, on radiotherapy days). Radiation therapy: 45 Gy in 25 fractions (5 d/wk).	Whether chemoradiotherapy after preoperative chemotherapy and adequate surgery leads to improved survival in comparison with postoperative chemotherapy.
			2 C (Active comparator): 3 courses q 3 w: epirubicin 50 mg/m2 (IV, day 1), cisplatin 60 mg/m2 (IV, day 1), capecitabine 1000 mg/m2 (bid, oral, day 1-14).
			All patients receive 3 cycles of the C in arm 2 before surgery.
Chemotherapy and radiation therapy after surgery in treating patients with stomach or esophageal cancer	Cancer and leukemia group B	824	1 (Active comparator): Patients receive leucovorin calcium IV and fluorouracil (5-FU) IV on days 1-5 of courses 1, 3 and 4. Courses repeat every 28 d. During course 2, patients undergo radiotherapy 5 d a week and receive 5-FU IV continuously for 5 wk. Patients rest for 28-35 d between course 2 and 3.	Compare overall survival in patients with resected gastric adenocarcinoma treated with epirubicin, cisplatin and infusional 5-FU vs 5-FU bolus and leucovorin calcium before and after 5-FU plus radiotherapy.
			2 (Experimental): Patients receive epirubicin IV over 3-15 min and cisplatin IV over 1 h on day 1 and 5-FU IV continuously on days 1-21 during course 1. Beginning 1 wk later, patients undergo radiotherapy 5 d a week and 5-FU IV continuously for 5 wk. Patients rest for 28-35 d before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin and 5-FU as in course 1. Treatment repeats every 21 d for 2 courses.

5-FU: 5-fluorouracil; LV: Leucovorin; CRT: Chemo-radiotherapy; C: Chemotherapy; q 1 w: Given every one week; bid: Given two times per day; q 3 w: Given every three weeks; IV: Intravenous.