Metastatic Colorectal CancerEarly Phase 1PERFORMNCT01410760
PERfusion CT in the FOXFIRE Trial to Study Blood Flow to Liver Metastases
A Early Phase 1 study testing Perfusion CT scan in people with Metastatic Colorectal Cancer, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The PERFORM study is a pilot study investigating the feasibility and usefulness of performing a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to normal CT scanning in patients recruited to the FOXFIRE trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Perfusion CT scan
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Apr 2013
- Phase
- Early Phase 1
- 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
Who may be able to join
- Patients who have given written informed consent to participate in the FOXFIRE clinical trial and have not yet started chemotherapy treatment in the trial.
- Serum creatinine and calculated glomerular filtration rate are less than the upper limit of normal (ULN) in blood tests performed up to 29 days before entry into the FOXFIRE clinical trial.
- Liver metastasis 1.0 to4.0 cm in cranio-caudal diameter on imaging performed up to 29 days before entry into the FOXFIRE clinical trial
Who cannot join
- True allergy to intravenous iodinated CT contrast
- Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this pilot study, at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Radcliffe Hospitals NHS Trust
Oxford, OX3 7LJ
Ricky A Sharma, MB BChir, 01865 617322, ricky.sharma@oncology.ox.ac.uk
Esme J Hill, MBChB
About this study
Official title: Perfusion Computed Tomography Pilot Study in the NCRN FOXFIRE Clinical Trial to Determine Blood Flow to Liver Metastases
The PERFORM study is a pilot study investigating the feasibility and usefulness of performing a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to normal CT scanning in patients recruited to the FOXFIRE trial. All patients recruited to FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester will be invited to take part. FOXFIRE is a national randomised controlled trial in which patients with unresectable liver tumours secondary to colorectal cancer will receive treatment with standard chemotherapy alone, or with chemotherapy in combination with an internal radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the liver via its own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan would usually be performed prior to the start of treatment and also three months after the commencement of treatment to assess the cancer's response to treatment, particularly whether the tumour has changed in size as a result of treatment. Perfusion CT gives the normal information on changes in tumour size but also assesses whether the blood flow to the cancer has changed, which may allow earlier identification of treatment success compared to normal CT scans. All patients consenting to participate in the PERFORM study will undergo four perfusion CT scans: one before the treatment starts, and one at the start of each of the second, third and fifth cycles of chemotherapy. The aim is to determine the feasibility of measuring tumour perfusion for data analysis using perfusion CT and to establish if the tumour perfusion pattern at baseline or shortly after the start of therapy can predict response to radioembolisation or chemotherapy. This research is funded by the National Institute for Health Research Biomedical Research Centre in Oxford and Oxfordshire Health Services Research Committee.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Perfusion CT scan
- Keywords
- Imaging study, Perfusion Computerised Tomography
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion CT scanOther
Patients in this imaging substudy of the FOXFIRE clinical trial will undergo a perfusion CT prior to FOXFIRE protocol therapy( Ox/MDG chemo alone for 12 cycles in arm A or OX+MDG chemo for 12 cycles with Yttrium 90 SIRshpheres liver radioembolisaton in arm B cycle 2) on Day 1/2 cycle 2, Day 1/2 cycle 3 and Day 1/2 cycle 5 chemotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate to this voluntary study and acquisition of sufficient data for perfusion analysis
Measured: 2 years
Secondary outcomes (1)
Correlation between the tumour perfusion pattern on perfusion CT studies at baseline and shortly after the start of therapy and morphological response by RECIST criteria on CT scan 3 months post therapy in both arms of the FOXFIRE trial.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Ricky A Sharma, MB BChir, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410760
- Sponsor's protocol ID
- 10/H0505/95
- Acronym
- PERFORM
- Status last verified
- Jun 2012
- First submitted
- 3 Aug 2011
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Computed Tomography Pilot Study in the NCRN FOXFIRE Clinical Trial to Determine Blood Flow to Liver Metastases
- ClinicalTrials.gov ID
- NCT01410760
- Acronym / sponsor ID
- PERFORM / 10/H0505/95
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Imaging study, Perfusion Computerised Tomography
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, University Hospitals, Leicester
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- First posted
- 5 Aug 2011 (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 PERFORM study is a pilot study investigating the feasibility and usefulness of performing a novel CT (Computed Tomography)scanning technique called Perfusion CT(CTP) as an addition to normal CT scanning in patients recruited to the FOXFIRE trial. All patients recruited to FOXFIRE at the Oxford Radcliffe Hospitals and University Hospitals of Leicester will be invited to take part. FOXFIRE is a national randomised controlled trial in which patients with unresectable liver tumours secondary to colorectal cancer will receive treatment with standard chemotherapy alone, or with chemotherapy in combination with an internal radiotherapy treatment which delivers radioactive particles(SIR-spheres) to the liver via its own blood supply (radioembolisation). In the FOXFIRE study a normal CT scan would usually be performed prior to the start of treatment and also three months after the commencement of treatment to assess the cancer's response to treatment, particularly whether the tumour has changed in size as a result of treatment. Perfusion CT gives the normal information on changes in tumour size but also assesses whether the blood flow to the cancer has changed, which may allow earlier identification of treatment success compared to normal CT scans. All patients consenting to participate in the PERFORM study will undergo four perfusion CT scans: one before the treatment starts, and one at the start of each of the second, third and fifth cycles of chemotherapy. The aim is to determine the feasibility of measuring tumour perfusion for data analysis using perfusion CT and to establish if the tumour perfusion pattern at baseline or shortly after the start of therapy can predict response to radioembolisation or chemotherapy. This research is funded by the National Institute for Health Research Biomedical Research Centre in Oxford and Oxfordshire Health Services Research Committee.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have given written informed consent to participate in the FOXFIRE clinical trial and have not yet started chemotherapy treatment in the trial.
- Serum creatinine and calculated glomerular filtration rate are less than the upper limit of normal (ULN) in blood tests performed up to 29 days before entry into the FOXFIRE clinical trial.
- Liver metastasis 1.0 to4.0 cm in cranio-caudal diameter on imaging performed up to 29 days before entry into the FOXFIRE clinical trial
Key exclusion criteria (2 listed)
- True allergy to intravenous iodinated CT contrast
- Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this pilot study, at the discretion of the investigator
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 |
|---|---|---|
| Perfusion CT scanPatients in this imaging substudy of the FOXFIRE clinical trial will undergo a perfusion CT prior to FOXFIRE protocol therapy( Ox/MDG chemo alone for 12 cycles in arm A or OX+MDG chemo for 12 cycles with Yttrium 90 SIRshpheres liver radioembolisaton in arm B cycle 2) on Day 1/2 cycle 2, Day 1/2 cycle 3 and Day 1/2 cycle 5 chemotherapy. | Other | – |
Primary outcome
Recruitment rate to this voluntary study and acquisition of sufficient data for perfusion analysis
Time frame: 2 years
1 secondary outcome
Correlation between the tumour perfusion pattern on perfusion CT studies at baseline and shortly after the start of therapy and morphological response by RECIST criteria on CT scan 3 months post therapy in both arms of the FOXFIRE trial.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
Related trials for Metastatic Colorectal Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer)
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Not yet recruitingObservational study
Real-World Treatment Patterns and Effectiveness of Anti-EGFR- and Anti-VEGF-based Therapies in Left-sided RAS Wild-Type Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
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.
Ricky A Sharma, MB BChir principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Perfusion CT scan in people with Metastatic Colorectal Cancer, run by University of Oxford 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 20 Jun 2012. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ricky A Sharma, MBBChir (01865 617322, Ricky.Sharma@oncology.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate to this voluntary study and acquisition of sufficient data for perfusion analysis (time frame: 2 years). 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 20 Jun 2012.