Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
|ClinicalTrials.gov Identifier: NCT00952926|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2009
Last Update Posted : November 17, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy|
|Actual Study Start Date :||October 2009|
|Actual Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||December 2018|
- Frequency of local recurrence [ Time Frame: 1 year ]
- Frequency of cumulative local recurrence [ Time Frame: Up to 5 years ]
- Frequency of distant metastases verified by planned PET/CT scans [ Time Frame: Up to 5 years. ]
- Overall survival [ Time Frame: Up to 5 years. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952926
|Vejle, Denmark, DK-7100|
|Principal Investigator:||Anders Jakobsen, DMSc||Vejle Hospital|