Phase I study of postoperative radiotherapy combined with capecitabine for gastric cancer

Table 1 Clinical target volume for elective nodal regions depending on the location of the primary gastric tumor²

Tumor location	CTV for elective nodal regions
Upper 1/3 or gastroesophageal junction	110, 1-3, 7, 9-11
Middle 1/3	1-3, 5-13, 141, 16a
Lower 1/3	3, 5-9, 11p, 12-13, 141, 16a

¹No. 14 was included in the clinical target volume (CTV) only when the surface or parenchyma of the pancreas was involved by the tumor; ²According to the guidelines issued by the Japanese Gastric Cancer Association. 110: Paraesophageal lymph nodes (LNs) in the lower thorax; 1: Right paracardial LNs; 2: Left paracardial LNs; 3: LNs along the lesser curvature; 5: Suprapyloric LNs; 6: Infrapyloric LNs; 7: LNs along the left gastric artery; 8: LNs along the common hepatic artery; 9: LNs around the celiac artery; 10: LNs at the splenic hilum; 11: LNs along the splenic artery (11p: LNs along the proximal splenic artery); 12: LNs in the hepatoduodenal ligament; 13: LNs on the posterior surface of the pancreatic head; 14: LNs along the root of the mesentery; 16a: LNs around the abdominal aorta (above the level of the inferior border of the left renal vein).

Table 2 Characteristics of the patients (n = 18) n (%)

Characteristic	Value
Median (range)	54 (29-66)
Men	12 (66.7)
Location of primary tumor
Upper 1/3	4 (22.2)
Middle 1/3	2 (11.1)
Lower 1/3	12 (66.7)
Surgery type
Proximal partial gastrectomy	4 (22.2)
Distal partial gastrectomy	12 (66.7)
Total gastrectomy	2 (11.1)
Extent of dissection
R0 (D1, D2)	12 (9, 3) (66.7)
R1	2 (11.1)
R2	4 (22.2)
Tumor differentiation
Well	1 (5.6)
Moderately	3 (16.7)
Poorly	14 (77.8)
Signet ring cell
Yes	9 (50.0)
No	9 (50.0)
Adjuvant chemotherapy
Yes	15 (83.3)
No	3 (16.7)
Stage (AJCC 7th)
II	3 (16.7)
III	15 (83.3)

AJCC: American Joint Committee on Cancer.

Table 3 Dose-limiting toxicities of chemoradiotherapy

Level	Capecitabine (mg/m2, bid)	n	No. patients with the DLT	DLT (G3/4)	RT dose when DLT occurred (Gy)
I	625	6	1	Nausea, vomiting, anorexia	5.4
II	700	6	1	Nausea, anorexia	45
III	800	6	1	Neutropenia	36
			1	Radiation esophagitis	43.2

DLT: Dose-limiting toxicity; RT: Radiotherapy.

Table 4 Grade 1-4 toxicities n (%)

Toxicity	Grade 1-2	Grade 3-4
Nausea	13 (72.2)	2 (11.1)
Vomiting	5 (27.8)	1 (5.6)
Diarrhea	2 (11.1)	0
Stomatitis	3 (16.7)	0
Anorexia	13 (72.2)	2 (11.1)
Fatigue	13 (72.2)	0
Weight loss	7 (38.9)	0
HFS	3 (16.7)	0
Esophagitis	0	1 (5.6)
Leukopenia	14 (77.8)	2 (11.1)
Neutropenia	3 (16.7)	1 (5.6)
Anemia	3 (16.7)	0
Thrombocytopenia	5 (27.8)	0
ALT/AST	0	0
Renal	0	0

HFS: Hand foot syndrome; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.