Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy|
- Frequency of local recurrence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Frequency of cumulative local recurrence [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Frequency of distant metastases verified by planned PET/CT scans [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952926
|Vejle, Denmark, DK-7100|