Trial Information

A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

Patients entering this study are offered the possibility of avoiding an extensive operation
and a permanent stoma.

Over the past 2 years Vejle Hospital examined patients with rectal cancer during their
course of treatment and we have developed a method to predict complete response.

Patients in this study are treated with chemotherapy and external irradiation supplemented
with an endorectal boost (2 fractions). At the start of treatment and weeks 2, 4, and 6 of
the treatment course an endoscopy is performed to evaluate the response. The final
evaluation is performed 6 weeks after end of treatment. Patients with complete remission are
offered observation. Patients with residual tumor are advised to be operated.

Follow-up is performed every 2 months the first year and every 3 months the second year. 2
follow-up visits are planned for the third year. A yearly follow-up is scheduled for the
fourth and fifth year.