Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

Universitair Ziekenhuis Brussel156 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Rectal Cancer

Interventions

ChemoradiotherapyOTHER

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

Radiotherapy with boostRADIATION

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

reduction in metabolic tumor activity

Time frame: at baseline and at 5 to 6 weeks after neo-adjuvant therapy

Secondary Outcomes

histological downgrading (Dworak classification)

pathological evaluation of surgical resection specimens

Time frame: after the rectum surgery

number of R0, R1 and R2 resections

pathological evaluation of surgical resection specimens

Time frame: after the rectum surgery

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

Time frame: at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years

local control

Time frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years

progression free survival

Time frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years

survival

overall survival

Time frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years

quality of life

Time frame: at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years

cost evaluation

Time frame: during the treatment and follow-ups

Data from ClinicalTrials.gov

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