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Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

Information source: Universitair Ziekenhuis Brussel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Cancer

Intervention: Chemoradiotherapy (Other); Radiotherapy with boost (Radiation)

Phase: Phase 3

Status: Recruiting

Sponsored by: Universitair Ziekenhuis Brussel

Official(s) and/or principal investigator(s):
Mark De Ridder, Prof.Dr., Principal Investigator, Affiliation: UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Overall contact:
Mark De Ridder, Prof.Dr., Phone: +3224776147, Email: mark.deridder@uzbrussel.be

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: reduction in metabolic tumor activity

Secondary outcome:

histological downgrading (Dworak classification)

number of R0, R1 and R2 resections

acute and late toxicity, according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

local control

progression free survival

survival

quality of life

cost evaluation

Eligibility

Minimum age: 18 Years. Maximum age: 95 Years. Gender(s): Both.

Criteria:

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 and Contacts

Mark De Ridder, Prof.Dr., Phone: +3224776147, Email: mark.deridder@uzbrussel.be

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie, Jette 1090, Belgium; Recruiting
Mark De Ridder, Prof.Dr., Phone: +3224776147, Email: mark.deridder@uzbrussel.be
Harijati Versmessen, MD, Phone: +3224763407, Email: harijati.versmessen@uzbrussel.be
Mark De Ridder, Prof.Dr., Principal Investigator
Benedikt Engels, MD, Sub-Investigator

UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie, Jette, Brussel 9010, Belgium; Recruiting
Mark De Ridder, Ph.D, Phone: +3224776147, Email: mark.deridder@uzbrussel.be
Harijati Versmessen, MD, Phone: +3224763407, Email: harijati.versmessen@uzbrussel.be
Mark De Ridder, Prof., Dr., Principal Investigator
Engels Benedikt, MD, Sub-Investigator

Additional Information

Starting date: January 2010
Last updated: April 29, 2013

Page last updated: August 23, 2015

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