NCT06024824 Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)
| NCT ID | NCT06024824 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Cancer Trials Ireland |
| Condition | Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 49 participants in total. It began in 2024-01-30 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06024824 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06024824 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06024824 currently recruiting?
Yes, NCT06024824 is actively recruiting participants. Contact the research team at info@cancertrials.ie for enrollment information.
Where is the NCT06024824 trial being conducted?
This trial is being conducted at Dublin, Ireland, Dublin, Ireland.
Who is sponsoring the NCT06024824 clinical trial?
NCT06024824 is sponsored by Cancer Trials Ireland. The trial plans to enroll 49 participants.