Colon CancertomoligoNCT00807313
Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer
An observational study of Colon Cancer and Rectal Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and more recently stereotactic body radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Colorectal Cancer
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2008to 30 Nov 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with oligometastatic (5 metastases or less) colorectal cancer
Who may be able to join
- Patients with (residual) oligometastatic CRC: ≤ 5 mets
- Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
- Functional liver volume > 1000cc if livermets, lung DLCO > 30% if lungmets.
- No Child B or C liver cirrhosis
- No contra-indications for radiation of all metastatic CRC (= no violation of constraints of organs at risk (OAR))
- No mets from another carcinoma
- Age > 18 years
- WHO-PS ≤ 2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
Brussels, 1090
About this study
Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and more recently stereotactic body radiotherapy. The aim of this study is to register the results and side effects of stereotactic body radiotherapy (SBRT) by means of helical tomotherapy in the treatment of oligometastatic colorectal cancer.
The trial has two cohorts. Patients in cohort I get consolidation SBRT after best response on first line chemotherapy. Patients in cohort II get SBRT when there is progression under, or no indication for (further) chemotherapy. The primary endpoint is to evaluate the metabolic complete remission rate three months after the start of radiotherapy.
- Conditions
- Colon Cancer, Rectal Cancer, Colorectal Cancer
- Keywords
- Oligometastatic disease, Colorectal cancer, Stereotactic body radiotherapy, Tomotherapy, Metabolic response, Stage IV
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| At best response | Patients with oligometastatic colorectal cancer, who presents at best response under chemotherapy, will receive stereotactic body radiotherapy on their residual disease | |
| No indication for chemotherapy | Patients with oligometastatic colorectal cancer, who are progressive under chemotherapy or who are no candidates for (further) chemotherapy, will receive stereotactic body radiotherapy on the sites of disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic complete remission rate
Measured: Three months
Secondary outcomes (5)
Acute toxicity
Measured: Three months
Progression free survival
Measured: Three to thirty six months
Local control
Measured: Three to thirty six months
Survival
Measured: Three to thirty six months
Late toxicity
Measured: Three to thirty six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2011
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark De Ridder, Universitair Ziekenhuis Brussel
- Investigators
- Mark De Ridder, MD, PhD, Principal investigator, UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807313
- Sponsor's protocol ID
- RCT501
- Acronym
- tomoligo
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2008
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Verellen D, De Ridder M, Linthout N, Tournel K, Soete G, Storme G. Innovations in image-guided radiotherapy. Nat Rev Cancer. 2007 Dec;7(12):949-60. doi: 10.1038/nrc2288.
PubMed 18034185Engels B, Gevaert T, Everaert H, De Coninck P, Sermeus A, Christian N, Storme G, Verellen D, De Ridder M. Phase II study of helical tomotherapy in the multidisciplinary treatment of oligometastatic colorectal cancer. Radiat Oncol. 2012 Mar 16;7:34. doi: 10.1186/1748-717X-7-34.
PubMed 22423615
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Observational Study of Helical Tomotherapy for Oligometastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00807313
- Acronym / sponsor ID
- tomoligo / RCT501
- Conditions
- Colon Cancer, Rectal Cancer, Colorectal Cancer
- Keywords
- Oligometastatic disease, Colorectal cancer, Stereotactic body radiotherapy, Tomotherapy, Metabolic response, Stage IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 11 Dec 2008 (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.
Patients with oligometastatic colorectal cancer (5 metastases or less) receive a combination of systemic treatment and often local treatment, such as surgery, radiofrequency ablation and more recently stereotactic body radiotherapy. The aim of this study is to register the results and side effects of stereotactic body radiotherapy (SBRT) by means of helical tomotherapy in the treatment of oligometastatic colorectal cancer.
The trial has two cohorts. Patients in cohort I get consolidation SBRT after best response on first line chemotherapy. Patients in cohort II get SBRT when there is progression under, or no indication for (further) chemotherapy. The primary endpoint is to evaluate the metabolic complete remission rate three months after the start of radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At best response | – | –Patients with oligometastatic colorectal cancer, who presents at best response under chemotherapy, will receive stereotactic body radiotherapy on their residual disease |
| No indication for chemotherapy | – | –Patients with oligometastatic colorectal cancer, who are progressive under chemotherapy or who are no candidates for (further) chemotherapy, will receive stereotactic body radiotherapy on the sites of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oligometastatic (5 metastases or less) colorectal cancer
Key inclusion criteria (8 listed)
- Patients with (residual) oligometastatic CRC: ≤ 5 mets
- Primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy)
- Functional liver volume > 1000cc if livermets, lung DLCO > 30% if lungmets.
- No Child B or C liver cirrhosis
- No contra-indications for radiation of all metastatic CRC (= no violation of constraints of organs at risk (OAR))
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic complete remission rate
Time frame: Three months
5 secondary outcomes
Acute toxicity
Time frame: Three months
Progression free survival
Time frame: Three to thirty six months
Local control
Time frame: Three to thirty six months
Survival
Time frame: Three to thirty six months
Late toxicity
Time frame: Three to thirty six months
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 29 Dec 2020.
- Background: PubMed 18034185Verellen D, De Ridder M, Linthout N, Tournel K, Soete G, Storme G. Innovations in image-guided radiotherapy. Nat Rev Cancer. 2007 Dec;7(12):949-60. doi: 10.1038/nrc2288.
- Derived from this study: PubMed 22423615Engels B, Gevaert T, Everaert H, De Coninck P, Sermeus A, Christian N, Storme G, Verellen D, De Ridder M. Phase II study of helical tomotherapy in the multidisciplinary treatment of oligometastatic colorectal cancer. Radiat Oncol. 2012 Mar 16;7:34. doi: 10.1186/1748-717X-7-34.
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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, MD, PhD principal investigator
UZ Brussel, Vrije Universiteit Brussel, dienst Radiotherapie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Rectal Cancer, run by Universitair Ziekenhuis Brussel at 1 site 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 8 inclusion and 0 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 29 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 1 site 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.
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?
Metabolic complete remission rate (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00807313, which also lists 2 linked publications.
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 29 Dec 2020.