Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

Phase 3

Completed

• Conditions: Rectal Cancer
• Interventions: Radiation: Radiotherapy with boost; Other: Chemoradiotherapy

• Registration Number: NCT01224392
• Lead Sponsor: Universitair Ziekenhuis Brussel

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy with boost	Radiotherapy with boost	Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
Concomitant chemoradiotherapy	Chemoradiotherapy	Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends

Primary Outcome Measures

Name	Time	Method
reduction in metabolic tumor activity	at baseline and at 5 to 6 weeks after neo-adjuvant therapy

Secondary Outcome Measures

Name	Time	Method
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
survival	every 6 months in the first year after completion of radiotherapy and then yearly until 3 years	overall survival
histological downgrading (Dworak classification)	after the rectum surgery	pathological evaluation of surgical resection specimens
progression free survival	every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
number of R0, R1 and R2 resections	after the rectum surgery	pathological evaluation of surgical resection specimens
local control	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
quality of life	at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years

Trial Locations

Locations (2)

UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie; 🇧🇪 Jette, Belgium

UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie; 🇧🇪 Jette, Brussel, Belgium