Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer (RectumSIB)
This study is currently recruiting participants.
Verified April 2013 by Universitair Ziekenhuis Brussel
Sponsor:
Universitair Ziekenhuis Brussel
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
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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
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 May 21, 2013