Status:
UNKNOWN
Preoperative Radiotherapy and Local Excision in Rectal Cancer
Lead Sponsor:
Polish Colorectal Cancer Study Group
Collaborating Sponsors:
Maria Sklodowska-Curie National Research Institute of Oncology
Poznan University of Medical Sciences
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
According to the current opinion, local excision in rectal cancer should be limited to selected T1N0 tumours. The investigators addressed the question whether preoperative radio(chemo)therapy can expa...
Detailed Description
Local excision must involve all tissue invaded on pretreatment examination. For this reason, 4-5 tatoos of mucosa at the tumour border should be performed before the onset of treatment. Next, the long...
Eligibility Criteria
Inclusion
- Biopsy proven good or moderately differentiated adenocarcinoma of rectum
- Extraperitoneal tumour (\< 3-4 cm; unfavourable cT1 or cT2-3; N0)
- No evidence of distant metastases on chest X-ray and abdominal CT or sonography
- Signed by patient written informed consent
Exclusion
- Poorly differentiated pathology (G3)
- Patients unfit for chemotherapy
- No agreement for randomisation
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2013
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00738790
Start Date
November 1 2003
End Date
November 1 2013
Last Update
April 15 2010
Active Locations (1)
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1
M. Sklodowska-Curie Memorial Cancer Centre
Warsaw, Poland, 02-781