Trial Information
Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
reduction in metabolic tumor activity
Outcome Time Frame:
at baseline and at 5 to 6 weeks after neo-adjuvant therapy
Safety Issue:
Yes
Principal Investigator
Mark De Ridder, Prof.Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
RectumSIB
NCT ID:
NCT01224392
Start Date:
January 2010
Completion Date:
December 2013
Related Keywords:
- Rectal Cancer
- colorectal cancer
- colorectal neoplasms
- radiotherapy
- chemoradiotherapy
- T3-4 rectal cancer
- Rectal Neoplasms