Phase II trials
N.
Design
RT dose
CR
Median F/U
3 yr DFS
3 yr CFS
OS
RTOG-0529 phase II completed accrual March 2008
63
5FU 1000 mg/m2 days 1–4 ad 29–33 2 doses of MMC 10 mg/m2 days 1, 29 Total dose = 20mg/m2
IMRT dose acc to T stage 50,4 Gy/28# T2NO 54Gy/30# for T3/T4NO 54 Gy/30# for T3/T4NO
34/61 67% at 8 weeks
No data
No data
No data
No data
ECOG E320510
62
NACT cisplat/5FUx2 induction, then 5FU/cisplat/cetuximab during RT in immunocompetent
54 Gy/30# for T3/T4NO
Study suspended 11/3/20018
No data
No data
No data
No data
AMC045
47
5FU 1000 mg/m2 days 1–4, cisplatin day 1, 29 cetuximabduring RT in HIV+
54 Gy/30# for T3/T4NO
Study ongoing
No data
No data
No data
No data
NCT0032444
15
FNCLCC
77
Cisplatin and 5FU with cetuximab
65 Gy
Study ongoing
No data
No data
No data
No data
NCT009551
40
Total
245
References
1.
2.
3.
4.
den Dulk M, Putter H, Collette L et al (2009) The abdominoperineal resection itself is associated with an adverse outcome: the European experience based on a pooled analysis of five European randomised clinical trials on rectal cancer. Eur J Cancer 45: 1175–1183CrossRef
5.
6.
7.
Peng J, Chen W, Sheng W et al (2011) Oncological outcome of T1 rectal cancer undergoing standard resection and local excision. Colorectal Dis 13: 14–19CrossRef
8.
9.
10.
11.
Doornebosh PG, Ferenschild FT, de Wilt JH et al (2010) Treatment of recurrence after transanal endoscopic microsurgery (TEM) for T1 rectal cancer. Dis Colon Rectum 53: 1234–1239CrossRef
12.
13.
Roedel C, Becker H, Fietkau R et al (2011) Preoperative chemoradiotherapy and postoperative chemotherapy with 5-fluorouracil and oxaliplatin versus 5-fluorouracil alone in locally advanced rectal cancer: First results of the German CAO/ARO/AIO-04 randomized phase III trial. J Clin Oncol 29(suppl):abs 3505
14.
15.
MERCURY study group (2007) Extramural depth of tumor invasion at thin-section MR in patients with rectal cancer: results of the MERCURY study. Radiology 243: 132–139CrossRef
16.
Peeters KC, van den Velde CJ, Leer JW et al (2005) Late side effects of short-course preoperative radiotherapy combined with total mesorectal excision for rectal cancer: increased bowel dysfunction in irradiated patients-a Dutch colorectal cancer group study. J Clin Oncol 23: 6199–6206PubMedCrossRef
17.
Schmoll HJ, Van Cutsem E, Stein A et al (2012) ESMO Consensus Guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making. Ann Oncol 23: 2479–2516PubMedCrossRef