Clinical trial NCT01224392: Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer
Official title: Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rectal Cancer
Keywords: colorectal cancer
colorectal neoplasms
radiotherapy
chemoradiotherapy
T3-4 rectal cancer
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
First posted: 2010-10-20
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: reduction in metabolic tumor activity
timeFrame: at baseline and at 5 to 6 weeks after neo-adjuvant therapy
Secondary outcomes:
measure: histological downgrading (Dworak classification)
timeFrame: after the rectum surgery
measure: number of R0, R1 and R2 resections
timeFrame: after the rectum surgery
measure: acute and late toxicity, according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
timeFrame: at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years
measure: local control
timeFrame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
measure: progression free survival
timeFrame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
measure: survival
timeFrame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
measure: quality of life
timeFrame: at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
measure: cost evaluation
timeFrame: during the treatment and follow-ups
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie
state: Brussel
city: Jette
country: Belgium
facility: UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Study officials:
affiliation: UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
name: Mark De Ridder, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: