Rectal Cancer
Conditions
Keywords
colorectal cancer, colorectal neoplasms, radiotherapy, chemoradiotherapy, T3-4 rectal cancer
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
Interventions
OTHERChemoradiotherapy
Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends
RADIATIONRadiotherapy with boost
Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
Sponsors
Vrije Universiteit Brussel
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction in metabolic tumor activity | at baseline and at 5 to 6 weeks after neo-adjuvant therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of R0, R1 and R2 resections | after the rectum surgery | pathological evaluation of surgical resection specimens |
| acute and late toxicity, according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years | — |
| local control | every 6 months in the first year after completion of radiotherapy and then yearly until 3 years | — |
| histological downgrading (Dworak classification) | after the rectum surgery | pathological evaluation of surgical resection specimens |
| survival | every 6 months in the first year after completion of radiotherapy and then yearly until 3 years | overall survival |
| quality of life | at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years | — |
| cost evaluation | during the treatment and follow-ups | — |
| progression free survival | every 6 months in the first year after completion of radiotherapy and then yearly until 3 years | — |
Countries
Belgium
Outcome results
None listed