MR-guided adaptive stereotactic radiotherapy in localised pancreatic cancer

Not Applicable

• Conditions: Cancer; ocally advanced pancreatic cancer; Malignant neoplasm of pancreas

• Registration Number: ISRCTN10557832
• Lead Sponsor: niversity of Oxford

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37709321/ (added 15/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-16
• Last Update Posted: 19 December 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT) within 3 months from the start of magnetic resonance guided radiotherapy (MRgRT), defined as: <br>1. Grade 3 upper gastrointestinal bleeding<br>2. Gastro-intestinal fistula (any grade)<br>3. Grade 4 nausea/vomiting uncontrolled despite optimum anti-emetics<br>4. Grade 4 pancreatitis not stent-related<br>5. Vascular events (where these are not considered to be tumour related)

Secondary Outcome Measures

Name	Time	Method
1. Efficacy of MRgRT up to 24 months follow-up, assessed using: <br>1.1. Overall survival and progression-free survival<br>1.2. Freedom from local progression <br>1.3. Freedom from metastatic progression<br>2. Definitive resection rate for those undergoing surgery evaluated at surgery: R0/R1/R2 resection margin rates; rate of pathological complete response<br>3. Long-term toxicity rates (only those specifically related to SBRT):<br>3.1. All Grade 3+ toxicities to 12 weeks from the start of MRgRT<br>3.2. Any late GI adverse events (AE) > grade 2 (CTC v5) after 12 weeks from the start of MRgRT<br>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