NCT00952926

Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.

Detailed description

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.

Conditions

• Rectal Cancer

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-01-01
• Completion: 2019-12-01
• First posted: 2009-08-06
• Last updated: 2020-02-05

Locations

1 site across 1 country: Denmark