Status:
UNKNOWN
The Randomised Study of Preoperative Radiotherapy With Consolidating Chemotherapy for Unresectable Rectal Cancer
Lead Sponsor:
Polish Colorectal Cancer Study Group
Collaborating Sponsors:
Maria Sklodowska-Curie National Research Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Cracow
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The addition of Oxaliplatin to conventionally fractionated chemoradiation (FULV or capecitabine) is considered as standard in unresectable rectal cancer by the panel of experts. The Investigators addr...
Detailed Description
Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases are randomly allocated to control or experimental arm. The preoperative treatment in t...
Eligibility Criteria
Inclusion
- Patients with unresectable primary rectal cancer or with unresectable local recurrence without distant metastases.
- WHO performance status ≤ 2.
- Lower border of tumour ≤ 15 cm from anal verge.
Exclusion
- cardiac coronary arterial disease,
- arrhythmias,
- stroke even if they have occurred in the past and are controlled with medication
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00833131
Start Date
November 1 2008
End Date
November 1 2015
Last Update
April 15 2010
Active Locations (1)
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1
M. Sklodowska-Curie Memorial Cancer Centre
Warsaw, Poland, 02-781