MR-guided adaptive stereotactic radiotherapy in localised pancreatic cancer

Trial ID: ISRCTN10557832

Other - Phase Unknown - No longer available

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

Conditions

• Locally advanced pancreatic cancer
• Cancer
• Malignant neoplasm of pancreas

Eligibility

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

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

Sponsor

University of Oxford

Source: https://www.isrctn.com/

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