Table 2

Two phase III studies investigating the role of adding oxaliplatin to preoperative chemoradiotherapy in rectal cancer

Study

Schema

N

Grade 3/4

toxicities (%)

LAR

pCR

Pathological

metastatic

disease (%)


STAR-01

Radiotherapy (59.4 Gy)

and 5-fluorouracil

379

8%

72%

16%

3%

(primary objective:


overall survival)

Radiotherapy, 5-fluorouracil

and oxaliplatin

368

24%

(p < 0.0001)

73%

16%

0.5%


ACCORD 12/0405

Radiotherapy (45 Gy) and

capecitabine

299

11%

73%

14%

4%

PRODIGE 2 (primary


objective: pCR)

Radiotherapy, capecitabine

and oxaliplatin

299

25%

(p < 0.0001)

76%

19%

3%


N: patient number; LAR: low anterior resection; pCR: pathological complete response

Javle and Hsueh Journal of Hematology & Oncology 2010 3:11   doi:10.1186/1756-8722-3-11

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