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Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer (RectumSIB)

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Chemoradiotherapy
Radiotherapy with boost
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring colorectal cancer, colorectal neoplasms, radiotherapy, chemoradiotherapy, T3-4 rectal cancer

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie
  • UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Concomitant chemoradiotherapy

Radiotherapy with boost

Arm Description

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

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

Outcomes

Primary Outcome Measures

reduction in metabolic tumor activity

Secondary Outcome Measures

histological downgrading (Dworak classification)
pathological evaluation of surgical resection specimens
number of R0, R1 and R2 resections
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)
local control
progression free survival
survival
overall survival
quality of life
cost evaluation

Full Information

First Posted
June 28, 2010
Last Updated
December 28, 2020
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT01224392
Brief Title
Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer
Acronym
RectumSIB
Official Title
Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Vrije Universiteit Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
colorectal cancer, colorectal neoplasms, radiotherapy, chemoradiotherapy, T3-4 rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concomitant chemoradiotherapy
Arm Type
Active Comparator
Arm Description
Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends
Arm Title
Radiotherapy with boost
Arm Type
Experimental
Arm Description
Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
Intervention Type
Other
Intervention Name(s)
Chemoradiotherapy
Other Intervention Name(s)
Xeloda (capecitabine)
Intervention Description
Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy with boost
Other Intervention Name(s)
Preoperative radiotherapy
Intervention Description
Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
Primary Outcome Measure Information:
Title
reduction in metabolic tumor activity
Time Frame
at baseline and at 5 to 6 weeks after neo-adjuvant therapy
Secondary Outcome Measure Information:
Title
histological downgrading (Dworak classification)
Description
pathological evaluation of surgical resection specimens
Time Frame
after the rectum surgery
Title
number of R0, R1 and R2 resections
Description
pathological evaluation of surgical resection specimens
Time Frame
after the rectum surgery
Title
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
Title
local control
Time Frame
every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
Title
progression free survival
Time Frame
every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
Title
survival
Description
overall survival
Time Frame
every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
Title
quality of life
Time Frame
at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
Title
cost evaluation
Time Frame
during the treatment and follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark De Ridder, Prof.Dr.
Organizational Affiliation
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie
City
Jette
State/Province
Brussel
ZIP/Postal Code
9010
Country
Belgium
Facility Name
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
City
Jette
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

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Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer

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