Status:
COMPLETED
Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborating Sponsors:
Vrije Universiteit Brussel
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-95 years
Phase:
PHASE3
Brief Summary
The investigators propose a randomized non-inferiority trial that compares preoperative Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In patients wit...
Eligibility Criteria
Inclusion
- histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
- the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound
Exclusion
- unresectable metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status \> 3
- patients not deemed fit for radiotherapy, capecitabine or surgery
- pregnant or lactating patients
- women with child bearing potential who lack effective contraception
- patients below 18 years old
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01224392
Start Date
January 1 2010
End Date
November 30 2020
Last Update
December 30 2020
Active Locations (2)
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1
UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie
Jette, Brussels Capital, Belgium, 9010
2
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Jette, Belgium, 1090