Status:
RECRUITING
Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Comprehen...
Detailed Description
The study treatment is radiotherapy. Different doses of radiotherapy will be given to patients. The first group of patients will receive the lowest dose (dose level 1) (this is the dose delivered to p...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06024824
Start Date
January 30 2024
End Date
July 1 2031
Last Update
July 20 2025
Active Locations (2)
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1
St Luke's Radiation Oncology Network (SLRON)
Dublin, Ireland
2
St Vincent's University Hospital
Dublin, Ireland