Rectal AdenocarcinomaORRECNCT04090450
Optimisation of Radiotherapy in Rectal Cancer (ORREC)
An observational study of Rectal Adenocarcinoma, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This is a retrospective study using images acquired routinely for diagnosis of rectal cancer to see if these could be used to predict responses to radiotherapy treatment and if it can, whether the treatment can be optimised to produce better outcome for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- chemo-radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2019to 31 Mar 2021
- 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
- Adult, Older adult
Study population: Patients who are treated with neo-adjuvant chemo-radiotherapy recruited from the clinical data of the Christie Hospital NHS databases
Who may be able to join
- Histologically confirmed rectal adenocarcinoma.
- Received pelvic radiotherapy (+/- chemotherapy) as neo-adjuvant treatment
- Age 18 and above
Who cannot join
- Other rectal pathologies.
- Patients less than 18yrs at diagnosis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Christie Hospital NHS Foundation Trust
Manchester, England, M20 4BX
Peter Mbanu, 01619183422, peter.mbanu@postgrad.manchester.ac.uk
About this study
Official title: Optimisation of Radiotherapy to Achieve Increased Organ Preservation in Rectal Cancer (ORREC)
This is a retrospective study using images acquired routinely for diagnosis of rectal cancer to see if these could be used to predict responses to radiotherapy treatment and if it can, whether the treatment can be optimised to produce better outcome for patients. Using a clinical database, patients who have had neo-adjuvant chemo-radiotherapy will be recruited, their diagnostic images and radiotherapy planning scan will be obtained. By use of imaging registration and clinical information, the question of why some patients respond well to radiotherapy and some don't could be answered.
Read the detailed description
The treatment of locally advanced rectal cancer is primarily radiotherapy (+/- chemotherapy) followed by surgery. The reason for radiotherapy is to reduce the risk of recurrence after surgery or to shrink the tumour first so that when surgery is done all the cancer will be successfully removed otherwise some will be left behind to grow. More than 80% of patients require a stoma after their surgery, some get reversed by two years after surgery but a third has it lifelong. About 15% of patients after radiotherapy have no disease left (clinical complete response) and can be monitored closely after radiotherapy and will not need to have surgery or stoma. Surgery carries a risk of death and complications, having a stoma have a lot of complications and have an effect on patient's quality of life, most end up not going out much and withdraws from friends and family due to the risk of accidents in public places. This study is aimed at looking at ways to increase the number of patients that do not require surgery after radiotherapy by looking at the differences between those that responded well to radiotherapy and the ones that did not by comparing their diagnostic and treatment scans. The main question to answer is why some patients have complete response to radiotherapy and others don't. Is there a way to increase the number of these patients through changes in radiotherapy? The study will be looking at the diagnostic images and radiotherapy planning scans to compare these two groups. Is there a way of predicting who will respond to radiotherapy treatment? If there is, modifications could be made to the type of treatment given. This study will be looking to radiomics techniques to develop this. This retrospective study will only make use of scans that patients have already had for their diagnosis and treatment so no patient intervention is required. Patients will be recruited using the clinical and research database of the Christie hospital which is the largest cancer centre in the UK. The study is funded by the charitable fund of the Christie Hospital NHS Foundation Trust.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- chemo-radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemo-radiotherapyRadiation
The study will not have a direct intervention. It will recruit patients who have had chemo-radiation as part of their standard of care treatment for rectal cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiotherapy volumes (cm^3)
The volume that receives radiotherapy treatment.
Measured: 24 months
Radiotherapy dose distribution (Gy/cm^3)
Radiotherapy dose delivered to a given volume
Measured: 24 months
MR radiomics extracted features.
Distinctive qualitative pixel features that can be extracted from area of disease in radiological images.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start23 Sep 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Responsible party
- Principal investigator, DR PETER MBANU, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090450
- Sponsor's protocol ID
- IRAS 265989
- Acronym
- ORREC
- Status last verified
- Sep 2019
- First submitted
- 11 Sep 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Radiotherapy to Achieve Increased Organ Preservation in Rectal Cancer (ORREC)
- ClinicalTrials.gov ID
- NCT04090450
- Acronym / sponsor ID
- ORREC / IRAS 265989
- Conditions
- Rectal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Study start
- 23 Sep 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 16 Sep 2019 (actual)
- 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.
This is a retrospective study using images acquired routinely for diagnosis of rectal cancer to see if these could be used to predict responses to radiotherapy treatment and if it can, whether the treatment can be optimised to produce better outcome for patients. Using a clinical database, patients who have had neo-adjuvant chemo-radiotherapy will be recruited, their diagnostic images and radiotherapy planning scan will be obtained. By use of imaging registration and clinical information, the question of why some patients respond well to radiotherapy and some don't could be answered.
Detailed description
The treatment of locally advanced rectal cancer is primarily radiotherapy (+/- chemotherapy) followed by surgery. The reason for radiotherapy is to reduce the risk of recurrence after surgery or to shrink the tumour first so that when surgery is done all the cancer will be successfully removed otherwise some will be left behind to grow. More than 80% of patients require a stoma after their surgery, some get reversed by two years after surgery but a third has it lifelong. About 15% of patients after radiotherapy have no disease left (clinical complete response) and can be monitored closely after radiotherapy and will not need to have surgery or stoma. Surgery carries a risk of death and complications, having a stoma have a lot of complications and have an effect on patient's quality of life, most end up not going out much and withdraws from friends and family due to the risk of accidents in public places. This study is aimed at looking at ways to increase the number of patients that do not require surgery after radiotherapy by looking at the differences between those that responded well to radiotherapy and the ones that did not by comparing their diagnostic and treatment scans. The main question to answer is why some patients have complete response to radiotherapy and others don't. Is there a way to increase the number of these patients through changes in radiotherapy? The study will be looking at the diagnostic images and radiotherapy planning scans to compare these two groups. Is there a way of predicting who will respond to radiotherapy treatment? If there is, modifications could be made to the type of treatment given. This study will be looking to radiomics techniques to develop this. This retrospective study will only make use of scans that patients have already had for their diagnosis and treatment so no patient intervention is required. Patients will be recruited using the clinical and research database of the Christie hospital which is the largest cancer centre in the UK. The study is funded by the charitable fund of the Christie Hospital NHS Foundation Trust.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are treated with neo-adjuvant chemo-radiotherapy recruited from the clinical data of the Christie Hospital NHS databases
Key inclusion criteria (3 listed)
- Histologically confirmed rectal adenocarcinoma.
- Received pelvic radiotherapy (+/- chemotherapy) as neo-adjuvant treatment
- Age 18 and above
Key exclusion criteria (2 listed)
- Other rectal pathologies.
- Patients less than 18yrs at diagnosis.
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 |
|---|---|---|
| chemo-radiotherapyThe study will not have a direct intervention. It will recruit patients who have had chemo-radiation as part of their standard of care treatment for rectal cancer. | Radiation | – |
Primary outcome
Radiotherapy volumes (cm^3)
Time frame: 24 months
The volume that receives radiotherapy treatment.
Radiotherapy dose distribution (Gy/cm^3)
Time frame: 24 months
Radiotherapy dose delivered to a given volume
MR radiomics extracted features.
Time frame: 24 months
Distinctive qualitative pixel features that can be extracted from area of disease in radiological images.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No
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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.
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 Rectal Adenocarcinoma, run by University of Manchester at 1 site in United Kingdom.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2019. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Mbanu (01619183422, peter.mbanu@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiotherapy volumes (cm^3) (time frame: 24 months). The study lists 3 primary outcomes in all. 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 16 Sep 2019.