MR-guided adaptive stereotactic radiotherapy in localised pancreatic cancer
| ISRCTN | ISRCTN10557832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10557832 |
| IRAS number | 279946 |
| Secondary identifying numbers | OCTRU-330, IRAS 279946, CPMD 52969 |
- Submission date
- 12/08/2022
- Registration date
- 16/08/2022
- Last edited
- 04/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-of-giving-radiotherapy-in-a-fewer-number-of-treatments-for-pancreatic-cancer-emerald
Background and study aims
An MR Linac combines two technologies – a magnetic resonance imaging (MRI) scanner and a conventional radiotherapy treatment machine (also known as a linear accelerator - Linac). Having radiotherapy (RT) on an MR Linac allows high-quality MR images to be taken daily before treatment and while the treatment is delivered with an associated adaptation of the radiotherapy treatment, called MR-guided adaptive RT. The optimal RT dose and schedule to treat pancreatic cancer are not known and doses have been limited by the need to keep the dose to normal surrounding tissues within accepted limits. Audit data has shown that when treatment is delivered on an MR Linac the tumour is targeted more effectively and normal tissues can be avoided. There is therefore the potential to safely deliver higher doses whilst keeping the dose to normal tissues within accepted limits. This study will evaluate whether increased RT doses and treatment over fewer days can be safely delivered to patients with pancreatic cancer on an MR Linac and whether this will improve the benefit of MR Linac treatment further. This study will also look at whether there are any changes in the tumours and normal tissues over the course of RT that can be seen on the MR images taken by the MR Linac, with the aim to find indicators from the imaging which may in the future be used to plan treatment more individually. The researchers will also collect blood samples to evaluate any changes in the immune response.
Who can participate?
Patients aged 16 years or above scheduled to receive MRgRT for pancreatic cancer
What does the study involve?
There are three phases to recruitment for this study: an initial safety run-in, a focussed recruitment phase, and an expansion phase. A recruitment pause may be implemented in any phase for any regimen if deemed necessary at any time. Participants receive either 5, 3 or 1-fraction MR-guided stereotactic radiotherapy over 1-3 weeks. The assigned choice is dependent on the order the patient is referred.
What are the possible benefits and risks of participating?
The participants will be having state-of-the-art- treatment over a very short time period. It is unknown whether the higher dose of RT or giving RT over a shorter period causes more side effects.
Where is the study run from?
The Churchill Hospital and the Genesis Care Clinic (UK)
When is the study starting and how long is it expected to run for?
July 2022 to January 2025
Who is funding the study?
MRC Institute for Radiation Oncology, Department of Oncology, University of Oxford, John Black Charitable Foundation, University of Oxford/GenesisCare Collaboration fund
Who is the main contact?
Lynda Swan, octo-emerald@oncology.ox.ac.uk
Contact information
Public
Oncology Clinical Trials Office (OCTO)
Department of Oncology, The University of Oxford
Old Road Campus Research Building
Oxford
OX3 7DQ
United Kingdom
| Phone | +44 (0)1865 617084 |
|---|---|
| octo-emerald@oncology.ox.ac.uk |
Principal Investigator
MRC Oxford Institute for Radiation Oncology
Gray Laboratories
University of Oxford
Old Road Campus Research Building
Roosevelt Drive
Oxford
OX3 7DQ
United Kingdom
| Phone | +44 (0)1865 617415 |
|---|---|
| somnath.mukherjee@oncology.ox.ac.uk |
Study information
| Study design | Single-centre three-arm non-randomized interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | https://www.oncology.ox.ac.uk/clinical-trials/oncology-clinical-trials-office-octo/current-trials/emerald-pancreas |
| Scientific title | Evaluation of hypofractionated adaptive radiotherapy using the MR Linac in localised pancreatic cancer |
| Study acronym | EMERALD - Pancreas |
| Study objectives | To establish the safety of MR-guided hypofractionation stereotactic body radiotherapy (SBRT) in localised pancreatic cancer |
| Ethics approval(s) | Approved 07/07/2022, West Midlands - Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 1048010, +44 (0)207 1048141; blackcountry.rec@hra.nhs.uk), ref: 22/WM/0122 |
| Health condition(s) or problem(s) studied | Locally advanced pancreatic cancer |
| Intervention | 5, 3 or 1-fraction MR-guided stereotactic radiotherapy over 1-3 weeks. The assigned choice is dependent on the order the patient is referred. |
| Intervention type | Other |
| Primary outcome measure | Dose Limiting Toxicity (DLT) within 3 months from the start of magnetic resonance guided radiotherapy (MRgRT), defined as: 1. Grade 3 upper gastrointestinal bleeding 2. Gastro-intestinal fistula (any grade) 3. Grade 4 nausea/vomiting uncontrolled despite optimum anti-emetics 4. Grade 4 pancreatitis not stent-related 5. Vascular events (where these are not considered to be tumour related) |
| Secondary outcome measures | 1. Efficacy of MRgRT up to 24 months follow-up, assessed using: 1.1. Overall survival and progression-free survival 1.2. Freedom from local progression 1.3. Freedom from metastatic progression 2. Definitive resection rate for those undergoing surgery evaluated at surgery: R0/R1/R2 resection margin rates; rate of pathological complete response 3. Long-term toxicity rates (only those specifically related to SBRT): 3.1. All Grade 3+ toxicities to 12 weeks from the start of MRgRT 3.2. Any late GI adverse events (AE) > grade 2 (CTC v5) after 12 weeks from the start of MRgRT 4. Freedom from further line chemotherapy: time from the start of MRgRT to re-start of further chemotherapy, anytime from the start of MRgRT up to 24 months |
| Overall study start date | 07/07/2022 |
| Completion date | 31/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Up to 60 |
| Total final enrolment | 25 |
| Key inclusion criteria | 1. Participants must be fit and scheduled to receive MRgRT for pancreatic cancer. There are no specific restrictions on tumour size, number or interval from diagnosis 2. Localised pancreatic cancer, which may be 2.1. Locally advanced and inoperable pancreatic cancer 2.2. Inoperable on medical grounds 2.3. Operable, but patient declines surgery 2.4. Locally recurrent pancreatic cancer 3. Histologically proven pancreatic ductal adenocarcinoma or cytological proven pancreatic malignancy. Where histology/cytology is ‘suspicious’ MDT should confirm that it is appropriate to treat as malignancy 4. Male or Female, aged 16 years or above 5. Life expectancy of at least 6 months 6. ECOG performance status 0-1 7. Haematological and biochemical indices within defined ranges: 7.1. Haemoglobin (Hb) ≥8.0 g/dL 7.2. Platelet count ≥50 x 10e9/l 7.3. Neutrophils ≥1.0 x 10e9/l 7.4. Total bilirubin ≤1.5 x IULN 7.5. AST(SGOT) or ALT(SGPT) ≤ 3.0 x IULN 8. Able (in the investigators’ opinion) and willing to comply with all study requirements for the duration of the study 9. Willing and able to give informed consent |
| Key exclusion criteria | 1. Patients with specific MRI exclusion criteria – metallic implants, shrapnel, claustrophobia or other expected intolerance of prolonged (up to 90 minutes) stay in an MRI scanner 2. Prior radiotherapy to the upper abdomen 3. Pregnant or breastfeeding women, or women of childbearing potential unless effective methods of contraception are used. Male patients who do not agree to use a condom during RT treatment and for 3 months after or who are not surgically sterile. 4. Distant metastatic disease or local disease that cannot be encompassed in the SBRT field |
| Date of first enrolment | 24/08/2022 |
| Date of final enrolment | 09/11/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Sponsor information
University/education
Research Governance, Ethics & Assurance (RGEA)
Boundary Brook House
Churchill Drive
Oxford
OX3 7GB
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
| Website | http://www.oucru.org/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
No information available
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The John Black Charitable Foundation, JBCF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data collected for the study, including individual participant data and a data dictionary defining each field in the set, will be made available to researchers on request to the study team and with appropriate reason, via octo-enquiries@oncology.ox.ac.uk. The shared data will be de-identified participant data and will be available for 3 years following the publication of the study. Data will be shared with investigator support, after approval of a proposal and with a signed data access agreement. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 14/09/2023 | 15/09/2023 | Yes | No |
Editorial Notes
04/03/2025: The overall study end date was changed from 31/12/2024 to 31/01/2025.
07/12/2023: The recruitment end date was changed from 01/03/2024 to 09/11/2023. Total final enrolment added.
15/09/2023: Publication reference added.
26/07/2023: Contact details updated. IPD sharing statement added.
02/03/2023: Trial website added.
03/02/2023: Cancer Research UK plain English summary link added to plain English summary field.
05/09/2022: Internal review.
15/08/2022: Trial's existence confirmed by the West Midlands - Black Country Research Ethics Committee.
