Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)
Recruiting now · Phase 1/Phase 2
Conditions studied: Pancreatic Adenocarcinoma
In brief
This is a prospective non-randomised Phase I/II Radiotherapy (RT) study with patients recruited to escalated dose cohorts. Patients with resectable or borderline resectable (per the National Comprehensive Cancer Network (NCCN) criteria) pancreatic adenocarcinoma will receive dose-escalated hypofractionated DP-IMRT via Intensity Modulated Radiotherapy (IMRT) / Volume Modulated Arc Therapy (VMAT).
Key facts
- Study ID
- NCT06024824
- Run by
- Cancer Trials Ireland
- People needed
- 49
- Starts
- 2024-01-30
- Expected to finish
- 2031-07-01
- Last updated by the study team
- 2025-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent obtained prior to any study-related procedures
- Age ≥18 years
- ECOG (European Cooperative Oncology Group) performance status (PS) 0-2
- Resectable or borderline resectable per National Comprehensive Cancer Network (NCCN) criteria (see Appendix H)
- 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
- Imaging with Computed Tomography Thorax Abdomen and Pelvis (CT TAP) and Magnetic resonance imaging (MRI) Abdomen confirms no evidence of metastatic disease
- 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.
You may not qualify if…
- Previous thoracic or abdominal or pelvic radiation therapy (RT)
- Previous treatment for bilirubin regression, other than stenting
- 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
- Syndromes or conditions associated with increased radiosensitivity
- 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
- 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 it is running
- St Luke's Radiation Oncology Network (SLRON) — Dublin, Ireland (enrolling)
- St Vincent's University Hospital — Dublin, Ireland (enrolling)
Full record on ClinicalTrials.gov
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