Anal CancerARTNCT02145416
ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy
An observational study of Anal Cancer, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This is a single arm, single centre imaging study which will be offered to all consecutive, eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within Oxford University Hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jan 2015to 12 Apr 2018
- 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: Eligible patients receiving radical CRT for anal cancer within Oxford University Hospitals
Who may be able to join
- Histologically confirmed invasive primary squamous carcinoma of the anus.
- Patients must be fit and scheduled to receive radical CRT with curative intent.
- Any stage tumor 2-node 0 (T2N0)
- Male or female, Age 18 years+.
- The patient is willing and able to comply with the images and protocol for the duration of the study.
- Written (signed and dated) informed consent.
Who cannot join
- Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used.
- Previous pelvic radiotherapy
- Patients with a pacemaker or any other implanted metal which would preclude MRI scan.
- Patients with a prosthetic hip.
- Patients receiving radiotherapy with palliative intent.
- Active medical or psychological illness that would render the patient unsuitable for the additional imaging proposed in this study, at the discretion of the investigator
Show all 9Show fewer
- Additional criteria for optional oxygen breathing procedure:
- Patients with Chronic Obstructive Pulmonary Disease
- Any patient not felt to be suitable for supplementary oxygen as considered by an appropriately trained clinician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy
This is a single arm, single centre imaging study which will be offered to all consecutive, eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within Oxford University Hospitals.
Investigations
Read more
- Dynamic contrast enhanced magnetic resonance imaging (DCE MRI)
- Diffusion weighted magnetic resonance imaging (DWI MRI)
- MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI)
- MRI scan designed to measure the T2* or produce T2*-weighed images (T2* MRI)
- Perfusion computed tomography (pCT)
- Fludeoxyglucose positron emission tomography (FDG PET/CT)
Study Design: Observational
Target Population: Patients undergoing radical CRT for anal cancer in Oxford University Hospitals National Health Service (NHS) Trust.
Duration on study: Patients should be on study for a maximum of 5 months.
Patient care post-trial: Follow up as per local standard.
No. of Study Site(s): Single Centre, United Kingdon (UK)
End of study: Last Patient, last assessment of response. Patients should be on study for a maximum of 5 months.
- Conditions
- Anal Cancer
- Keywords
- Imaging, Chemoradiotherapy
- Medical subject headings
- Anus Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on DW MRI during CRT in anal cancer.
The number of patients with a change in ADC values of <20% between pre-CRT DW MRI and repeat DW MRI following 8-10 fractions of CRT
Measured: Fraction 8-10 of CRT (Day 10-12) compared with prior to CRT (Day 1)
Secondary outcomes (4)
Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET
Changes on alternative functional imaging modalities following 8-10 fractions of CRT:
- DCE MRI - Change in amplitude and rate of gadolinium enhancement.
- Perfusion CT - Changes in perfusion maps represented by blood flow, blood volume, mean transition time and permeability surface area.
- T2* MRI - Change in T2* values in hypoxic regions (with or without oxygen)
- FDG PET - Change in tumour uptake (% change in SUVmax).
Measured: Fraction 8-10 of CRT (Day 10-12)
Correlation of findings on different functional images.
Correlate size and position of regions of poor vascularity / hypoxia between different images at the same timepoint using volume, centre of mass and overlap comparisons.
Measured: Both prior to CRT day 1 and fraction 8-10
Correlation of baseline functional images with outcome of CRT
Compare volumes of poor vascularity / hypoxia in baseline scans (as described above) with complete response rates 3 months after CRT.
Measured: 3 months post CRT compared with prior to CRT (Day 1)
Correlation of the change in functional images over CRT with outcome of CRT
Change in volumes of poor vascularity / hypoxia in baseline scans (as described above) with complete response rates 3 months after CRT.
Measured: 3 months post CRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start27 Jan 2015
- Primary completion8 Dec 2017
- Study completion12 Apr 2018
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 Anal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Rebecca Muirhead, MBCHB, MRCP, FRCR, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145416
- Sponsor's protocol ID
- OCTO-051
- Acronym
- ART
- Status last verified
- Jun 2018
- First submitted
- 20 May 2014
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Robinson M, Muirhead R, Jacobs C, Cooke R, Chu KY, Van den Heuvel F, Ng S, Virdee P, Strauss V, Hawkins M. Response of FDG avid pelvic bone marrow to concurrent chemoradiation for anal cancer. Radiother Oncol. 2020 Feb;143:19-23. doi: 10.1016/j.radonc.2019.08.016. Epub 2019 Sep 7.
PubMed 31506182Sabbagh A, Jacobs C, Cooke R, Chu KY, Ng SM, Strauss VY, Virdee PS, Hawkins MA, Aznar MC, Muirhead R. Is There a Role for an 18F-fluorodeoxyglucose-derived Biological Boost in Squamous Cell Anal Cancer? Clin Oncol (R Coll Radiol). 2019 Feb;31(2):72-80. doi: 10.1016/j.clon.2018.11.034. Epub 2018 Dec 21.
PubMed 30583927
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy
- ClinicalTrials.gov ID
- NCT02145416
- Acronym / sponsor ID
- ART / OCTO-051
- Conditions
- Anal Cancer
- Keywords
- Imaging, Chemoradiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 22 May 2014 (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.
This is a single arm, single centre imaging study which will be offered to all consecutive, eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within Oxford University Hospitals.
Investigations
- Dynamic contrast enhanced magnetic resonance imaging (DCE MRI)
- Diffusion weighted magnetic resonance imaging (DWI MRI)
- MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI)
- MRI scan designed to measure the T2* or produce T2*-weighed images (T2* MRI)
- Perfusion computed tomography (pCT)
- Fludeoxyglucose positron emission tomography (FDG PET/CT)
Study Design: Observational
Target Population: Patients undergoing radical CRT for anal cancer in Oxford University Hospitals National Health Service (NHS) Trust.
Duration on study: Patients should be on study for a maximum of 5 months.
Patient care post-trial: Follow up as per local standard.
No. of Study Site(s): Single Centre, United Kingdon (UK)
End of study: Last Patient, last assessment of response. Patients should be on study for a maximum of 5 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients receiving radical CRT for anal cancer within Oxford University Hospitals
Key inclusion criteria (6 listed)
- Histologically confirmed invasive primary squamous carcinoma of the anus.
- Patients must be fit and scheduled to receive radical CRT with curative intent.
- Any stage tumor 2-node 0 (T2N0)
- Male or female, Age 18 years+.
- The patient is willing and able to comply with the images and protocol for the duration of the study.
Key exclusion criteria (9 listed)
- Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used.
- Previous pelvic radiotherapy
- Patients with a pacemaker or any other implanted metal which would preclude MRI scan.
- Patients with a prosthetic hip.
- Patients receiving radiotherapy with palliative intent.
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
Changes on DW MRI during CRT in anal cancer.
Time frame: Fraction 8-10 of CRT (Day 10-12) compared with prior to CRT (Day 1)
The number of patients with a change in ADC values of <20% between pre-CRT DW MRI and repeat DW MRI following 8-10 fractions of CRT
4 secondary outcomes
Changes on DCE MRI, Perfusion CT, T2* MRI, FDG PET
Time frame: Fraction 8-10 of CRT (Day 10-12)
Correlation of findings on different functional images.
Time frame: Both prior to CRT day 1 and fraction 8-10
Correlation of baseline functional images with outcome of CRT
Time frame: 3 months post CRT compared with prior to CRT (Day 1)
Correlation of the change in functional images over CRT with outcome of CRT
Time frame: 3 months post CRT
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 6 Jun 2018.
- Derived from this study: PubMed 31506182Robinson M, Muirhead R, Jacobs C, Cooke R, Chu KY, Van den Heuvel F, Ng S, Virdee P, Strauss V, Hawkins M. Response of FDG avid pelvic bone marrow to concurrent chemoradiation for anal cancer. Radiother Oncol. 2020 Feb;143:19-23. doi: 10.1016/j.radonc.2019.08.016. Epub 2019 Sep 7.
- Derived from this study: PubMed 30583927Sabbagh A, Jacobs C, Cooke R, Chu KY, Ng SM, Strauss VY, Virdee PS, Hawkins MA, Aznar MC, Muirhead R. Is There a Role for an 18F-fluorodeoxyglucose-derived Biological Boost in Squamous Cell Anal Cancer? Clin Oncol (R Coll Radiol). 2019 Feb;31(2):72-80. doi: 10.1016/j.clon.2018.11.034. Epub 2018 Dec 21.
Related trials for Anal Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Study of Pembrolizumab, Carboplatin, Paclitaxel, and Radiation for the Treatment of Early-Stage Anal Cancer
Anal Cancer
Active, not recruitingPhase 2
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous Cell Carcinoma of the Anus Stage III
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
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.
Rebecca Muirhead, MBCHB, MRCP, FRCR, MD principal investigator
Oxford University Hospitals NHS Trust
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 Anal 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 6 inclusion and 9 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 6 Jun 2018. 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?
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?
Changes on DW MRI during CRT in anal cancer. (time frame: Fraction 8-10 of CRT (Day 10-12) compared with prior to CRT (Day 1)). 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 NCT02145416, 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 6 Jun 2018.