Dose-Painted Intensity Modulated Radiotherapy for Pancreatic Cancer
DP-IMRT Pancreas: A Non-randomised Phase I/II Study of Dose-escalated Hypofractionated Dose-Painted Intensity Modulated Radiotherapy (DPIMRT) in Resectable/Borderline Resectable Pancreatic Adenocarcinoma
This study is testing a new way of giving radiation therapy to people with certain types of pancreatic cancer to see how much they can safely handle and if it helps them better than standard treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Trials Ireland Research network |
| Drugs / interventions | radiation |
| Locations | 2 sites (Dublin and 1 other locations) |
| Trial ID | NCT06024824 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of dose-painted intensity modulated radiotherapy (DP-IMRT) for patients with resectable or borderline resectable pancreatic adenocarcinoma. It employs a dose escalation approach, where patients receive increasing doses of radiotherapy based on their tolerance to the treatment, starting from a standard care dose. The study aims to establish the maximum tolerated dose (MTD) in Phase I, followed by a larger cohort receiving this optimized dose in Phase II. The trial includes comprehensive imaging to confirm the absence of metastatic disease before treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed pancreatic ductal adenocarcinoma that is resectable or borderline resectable.
Not a fit: Patients with metastatic pancreatic cancer or those who do not meet the NCCN criteria for resectability may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with pancreatic adenocarcinoma by optimizing radiotherapy dosing.
How similar studies have performed: Other studies have shown promise with dose escalation in radiotherapy, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Written informed consent obtained prior to any study-related procedures 2. Age ≥18 years 3. ECOG (European Cooperative Oncology Group) performance status (PS) 0-2 4. Resectable or borderline resectable per National Comprehensive Cancer Network (NCCN) criteria (see Appendix H) 5. Patients with histologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC), with the following staging: cT1N0-2, cT2N0-2, cT3N0-2 \[American Joint Committee on Cancer (AJCC) 8th edition\] (see Appendix C) who are planned for pre-operative systemic chemo-radiotherapy 6. Imaging with Computed Tomography Thorax Abdomen and Pelvis (CT TAP) and Magnetic resonance imaging (MRI) Abdomen confirms no evidence of metastatic disease 7. Females of child-bearing potential (see Appendix G) must not be pregnant (or lactating) and must be prepared to use adequate contraception methods during treatment. Males whose female partners are of child-bearing potential must be prepared to use adequate contraception methods during treatment. Exclusion Criteria 1. Previous thoracic or abdominal or pelvic radiation therapy (RT) 2. Previous treatment for bilirubin regression, other than stenting 3. Known co-existing or prior malignancy within the last 5 years (except for Basal Cell Carcinoma (BCC) or Squamous Cell Carcinoma (SCC) of the skin) which is likely to interfere with treatment or assessment of outcomes 4. Syndromes or conditions associated with increased radiosensitivity 5. Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes, or psychiatric illness/ social situations that would limit compliance with study requirements 6. Evidence of any other significant clinical disorder or laboratory findings that makes it undesirable for the patient to participate in the study, or if it is felt by the research/ Medical team that the patient may not be able to comply with the protocol and follow up schedule due to psychological, familial, sociological or geographical conditions
Where this trial is running
Dublin and 1 other locations
- St Luke's Radiation Oncology Network (SLRON) — Dublin, Ireland (Recruiting)
- St Vincent's University Hospital — Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Cancer Trials Ireland
- Email: info@cancertrials.ie
- Phone: +35316677211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.