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Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer


Phase 3
18 Years
95 Years
Open (Enrolling)
Both
Rectal Cancer

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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

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