Rectal CancerPhase 3RectumSIBNCT01224392
Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer
A Phase 3 study testing Chemoradiotherapy and Radiotherapy with boost in people with Rectal Cancer, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Chemoradiotherapy and Radiotherapy with boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2010to 30 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
UZ Brussel , Vrije Universiteit Brussel, dienst Radiotherapie
Jette, Brussels Capital, 9010
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Jette, 1090
About this study
Official title: 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
- Conditions
- Rectal Cancer
- Being tested
- Chemoradiotherapy, Radiotherapy with boost
- Keywords
- colorectal cancer, colorectal neoplasms, radiotherapy, chemoradiotherapy, T3-4 rectal cancer
- Medical subject headings
- Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiotherapyOther
Also called Xeloda (capecitabine)
Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends
Radiotherapy with boostRadiation
Also called Preoperative radiotherapy
Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
| Study group | Role | What they receive |
|---|---|---|
| Concomitant chemoradiotherapy | Active comparator | Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends Receives: Other: Chemoradiotherapy |
| Radiotherapy with boost | Experimental | Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor Receives: Radiation: Radiotherapy with boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in metabolic tumor activity
Measured: at baseline and at 5 to 6 weeks after neo-adjuvant therapy
Secondary outcomes (8)
histological downgrading (Dworak classification)
pathological evaluation of surgical resection specimens
Measured: after the rectum surgery
number of R0, R1 and R2 resections
pathological evaluation of surgical resection specimens
Measured: after the rectum surgery
acute and late toxicity, according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Measured: at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years
local control
Measured: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
progression free survival
Measured: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
survival
overall survival
Measured: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
quality of life
Measured: at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
cost evaluation
Measured: during the treatment and follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJan 2010
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Mark De Ridder, Universitair Ziekenhuis Brussel
- Investigators
- Mark De Ridder, Prof.Dr., Principal investigator, UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224392
- Sponsor's protocol ID
- RectumSIB
- Acronym
- RectumSIB
- Status last verified
- Dec 2020
- First submitted
- 28 Jun 2010
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer
- ClinicalTrials.gov ID
- NCT01224392
- Acronym / sponsor ID
- RectumSIB / RectumSIB
- Conditions
- Rectal Cancer
- Keywords
- colorectal cancer, colorectal neoplasms, radiotherapy, chemoradiotherapy, T3-4 rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- Jan 2010
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concomitant chemoradiotherapy | Active comparator | Other: ChemoradiotherapyRadiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends |
| Radiotherapy with boost | Experimental | Radiation: Radiotherapy with boostRadiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoradiotherapyAlso: Xeloda (capecitabine)Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends | Other | Concomitant chemoradiotherapy |
| Radiotherapy with boostAlso: Preoperative radiotherapyRadiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor | Radiation | Radiotherapy with boost |
Primary outcome
reduction in metabolic tumor activity
Time frame: at baseline and at 5 to 6 weeks after neo-adjuvant therapy
8 secondary outcomes
histological downgrading (Dworak classification)
Time frame: after the rectum surgery
number of R0, R1 and R2 resections
Time frame: after the rectum surgery
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
local control
Time frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
progression free survival
Time frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
survival
Time frame: every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
quality of life
Time frame: at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years
cost evaluation
Time frame: during the treatment and follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark De Ridder, Prof.Dr. principal investigator
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemoradiotherapy and Radiotherapy with boost in people with Rectal Cancer, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in metabolic tumor activity (time frame: at baseline and at 5 to 6 weeks after neo-adjuvant therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.