You are here:

Intervention protocol 10

Observational study on contact X-ray and transanal endoscopic microsurgery in curative treatment of rectal cancer (CONTEM)

Objectives Standard curative treatment of rectal cancer is today total mesorectal excision (TME). The mortality rate for the TME procedure is about 6% and 30-40% of the patients will develop serious late effects. Alternatively contact X-ray (CXR) with a hand-held 50 kV tube can be used to deliver radiation through a rigid proctoscope directly to the surface of the tumour. Because of the low energy involved in CXR and the resulting sharp fall off of dose (25% at 10 mm) it is possible to deliver curative doses (80-120 Gy in 3-5 fractions) with out superseding the normal tissue tolerance. A new CXR machine is now commercially available. The study aim is to evaluate the efficacy and morbidity of organ preserving treatment of early stage rectal cancer by use of contact X-ray, concomitant chemo-radiotherapy and TEM in a multicenter study.
Study outline (intervention) The CONTEM study will be running from Dec. 2008 and the aim is to recruit > 300 patients in 4 years and follow them for at least another 3 years. More than 10 centres around the world with expertise in contact X-ray and TEM will participate. The primary endpoint is local control with disease free survival, overall survival, morbidity and organ function as secondary endpoints. Functional anorectal assessment will be performed by impedance planimetry. Morbidity and quality of life will be investigated by use of CTCAE v3.0 and EORTC C30.
Expected impact Based on the experience collected so far, CXR will play a major role in the treatment of early rectal cancer especially in an ageing population with much co-morbidity. With the present stage and age distribution we expect that 20-30 patients yearly in Denmark alone will be spared a colostomy by use of CXR.
Linkages with work packages WP 1, 2, 4, 7, 9. Tools from WP01 and WP02: individual radiobiological profile. From WP04: imaging. From WP07 new markers, From WP09: analysis