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COMPLETEDPHASE3

Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

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

NCT01224392•Universitair Ziekenhuis Brussel

View on ClinicalTrials.gov

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 with T3-4 rectal cancer, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be used as a surrogate marker of cause specific outcome

Eligibility

Age

18 - 95 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie

Jette, Brussels Capital, Belgium

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Jette, Belgium

Key Dates

Start Date

January 1, 2010

Primary Completion Date

November 30, 2020

Completion Date

November 30, 2020

Last Updated

December 30, 2020

Enrollment

156

ESTIMATED participants

Conditions

Rectal Cancer

Interventions

Chemoradiotherapy

OTHER

Radiotherapy with boost

RADIATION

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

Inclusion Criteria

Exclusion Criteria

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