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Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

NCT ID: NCT01224392

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Rectal Cancer

Keywords

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colorectal cancer colorectal neoplasms radiotherapy chemoradiotherapy T3-4 rectal cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Concomitant chemoradiotherapy

Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends

Group Type ACTIVE_COMPARATOR

Chemoradiotherapy

Intervention Type OTHER

Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends

Radiotherapy with boost

Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor

Group Type EXPERIMENTAL

Radiotherapy with boost

Intervention Type RADIATION

Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor

Interventions

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Chemoradiotherapy

Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends

Intervention Type OTHER

Radiotherapy with boost

Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor

Intervention Type RADIATION

Other Intervention Names

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Xeloda (capecitabine) Preoperative radiotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Mark De Ridder

Head of Radiotherapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark De Ridder, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Locations

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UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie

Jette, Brussels Capital, Belgium

Site Status

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Jette, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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RectumSIB

Identifier Type: -

Identifier Source: org_study_id