EMERALD Pancreas
Evaluation of hypofractionated adaptive radiotherapy using the MR Linac in localised pancreatic cancer
Full Title
Evaluation of hypofractionated adaptive radiotherapy using the MR Linac in localised pancreatic cancer
Chief Investigator: Dr Somnath Mukherjee
EMERALD Pancreas is now CLOSED TO RECRUITMENT – the trial is now in follow up
Study Design
This is a single centre three-arm phase 1 non-randomised, open, safety study.
Online adaptive magnetic resonance guided radiotherapy (MRgRT) allows for dose escalation to pancreatic cancer while sparing surrounding critical organs. The study seeks to evaluate the safety of delivering hypofractionated five, three and single fraction MR-guided stereotactic ablative radiotherapy (SABR) to the pancreas.
Patients with localised pancreatic cancer will receive either 50Gy in five- (BED10 =100Gy), 39Gy in three- (BED10 90Gy), or 25Gy in a single fraction (BED10 =87.5Gy) MR-guided daily online adaptive radiotherapy. There are three phases of recruitment to the study: an initial safety run-in, a focussed recruitment phase, and an expansion phase.
Study Population
The target population for the Emerald-Pancreas trial consists of male or female aged 16 years or above with an ECOG performance status of 0-1 with a localised pancreatic cancer
Lay Summary
A Lay Summary of this study is available on the CRUK Website: CLICK HERE
Study Schema
Target recruitment
Maximum 60 patients
Participating Sites
Churchill Hospital, Oxford (Oxford University Hospital NHS Foundation Trust), with patients treated on the Viewray MRIdian at the GenesisCare site in Oxford.
Inclusion Criteria
A patient will be eligible for inclusion in this study if all of the following criteria apply.
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
a. locally advanced and inoperable pancreatic cancer
b. inoperable on medical grounds
c. operable, but patient declines surgery
d. 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:
|
Lab Test |
Value required |
|
Haemoglobin (Hb) |
≥ 8.0 g/dL |
|
Platelet count |
≥50 x 109/l; |
|
Neutrophils |
≥ 1.0 x 109/l. |
|
Total bilirubin |
≤ 1.5 x IULN |
|
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.
Exclusion Criteria
A patient will not be eligible for the trial if any of the following apply:
1. Patients with specific MRI exclusion criteria – metallic implants, shrapnel, claustrophobia or other expected intolerance of prolonged (up to 90 minutes) stay in MRI scanner.
2. Prior radiotherapy to the upper abdomen
3. Pregnant or breast-feeding 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 three months after or who are not surgically sterile.
4. Distant metastatic disease or local disease that cannot be encompassed in the SBRT field.
Primary Objective
To establish the safety of MR-guided hypofractionation SBRT in localised pancreatic cancer
Key Dates
- Opened to recruitment: 18th August 2022
- First patient registered: 25th August 2022
- Study now closed to recruitment, nd closed for follow up.
- Expected study analysis and close-out date: 31st December 2024
Contact Us
EMERALD Trial Office
octo-emerald@oncology.ox.ac.uk