Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer (RectumSIB)

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

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 Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Other: Chemoradiotherapy; Radiation: Radiotherapy with boost

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
  • Brussel
    • Jette, Brussel, Belgium, 9010
      • UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Concomitant chemoradiotherapy; Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends	Other: Chemoradiotherapy; Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends; Other Names: Xeloda (capecitabine)
Experimental: Radiotherapy with boost; Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor	Radiation: Radiotherapy with boost; Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor; Other Names: Preoperative radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reduction in metabolic tumor activity	at baseline and at 5 to 6 weeks after neo-adjuvant therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
histological downgrading (Dworak classification)	pathological evaluation of surgical resection specimens	after the rectum surgery
number of R0, R1 and R2 resections	pathological evaluation of surgical resection specimens	after the rectum surgery
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
progression free survival		every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
survival	overall survival	every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Vrije Universiteit Brussel
• Investigators: Principal Investigator: Mark De Ridder, Prof.Dr., UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 28, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (Estimate): October 20, 2010

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: colorectal cancer; radiotherapy; colorectal neoplasms; chemoradiotherapy; T3-4 rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: RectumSIB