Status:
COMPLETED
Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
Lead Sponsor:
Vejle Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Brief 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 the...
Eligibility Criteria
Inclusion
- Histopathologically verified adenocarcinoma in the rectum
- Planned APR or ultra low resection
- Primary resectable T2 or T3 tumor
- Distance from anus to lower edge of tumor ≤ 6 cm
- Suited for curative intended radiation and chemotherapy
- Accept taking of biopsy and blood samples for translational research
- Age ≥ 18 years
- Normal function of bone marrow
- leukocytes ≥ 3 x 10\^9/l
- thrombocytes ≥ 100
- Normal liver function
- ALAT \< 2.5 x upper normal value
- bilirubin \< 2.5 x upper normal value
- Renal function
- Serum creatinin \< 1.5 x upper normal value
- Written and orally informed consent
Exclusion
- Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri
- Distant metastases
- Pregnant or breast feeding patients
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00952926
Start Date
October 1 2009
End Date
December 1 2019
Last Update
February 5 2020
Active Locations (1)
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1
Vejle Hospital
Vejle, Denmark, DK-7100