Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer (RectumSIB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Universitair Ziekenhuis Brussel
Sponsor:
Collaborator:
Vrije Universiteit Brussel
Information provided by (Responsible Party):
Mark De Ridder, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01224392
First received: June 28, 2010
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Rectal Cancer
Other: Chemoradiotherapy
Radiation: Radiotherapy with boost
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • reduction in metabolic tumor activity [ Time Frame: at baseline and at 5 to 6 weeks after neo-adjuvant therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • histological downgrading (Dworak classification) [ Time Frame: after the rectum surgery ] [ Designated as safety issue: No ]
    pathological evaluation of surgical resection specimens

  • number of R0, R1 and R2 resections [ Time Frame: after the rectum surgery ] [ Designated as safety issue: No ]
    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) [ Time Frame: at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years ] [ Designated as safety issue: Yes ]
  • local control [ Time Frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years ] [ Designated as safety issue: No ]
  • survival [ Time Frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years ] [ Designated as safety issue: No ]
    overall survival

  • quality of life [ Time Frame: at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years ] [ Designated as safety issue: No ]
  • cost evaluation [ Time Frame: during the treatment and follow-ups ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Preoperative radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224392

Contacts
Contact: Mark De Ridder, Prof.Dr. +3224776147 mark.deridder@uzbrussel.be
Contact: Harijati Versmessen, MD +3224763407 harijati.versmessen@uzbrussel.be

Locations
Belgium
UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie Recruiting
Jette, Brussel, Belgium, 9010
Contact: Mark De Ridder, Ph.D    +3224776147    mark.deridder@uzbrussel.be   
Contact: Harijati Versmessen, MD    +3224763407    harijati.versmessen@uzbrussel.be   
Principal Investigator: Mark De Ridder, Prof., Dr.         
Sub-Investigator: Engels Benedikt, MD         
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie Recruiting
Jette, Belgium, 1090
Contact: Mark De Ridder, Prof.Dr.    +3224776147    mark.deridder@uzbrussel.be   
Contact: Harijati Versmessen, MD    +3224763407    harijati.versmessen@uzbrussel.be   
Principal Investigator: Mark De Ridder, Prof.Dr.         
Sub-Investigator: Benedikt Engels, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel
Investigators
Principal Investigator: Mark De Ridder, Prof.Dr. UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
  More Information

No publications provided

Responsible Party: Mark De Ridder, Head of Radiotherapy Department, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01224392     History of Changes
Other Study ID Numbers: RectumSIB
Study First Received: June 28, 2010
Last Updated: April 29, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitair Ziekenhuis Brussel:
colorectal cancer
colorectal neoplasms
radiotherapy
chemoradiotherapy
T3-4 rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014