RecruitingPhase 1Phase 2NCT06024824

Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)

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

Sponsor

Cancer Trials Ireland

Enrollment

49 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

Pancreatic Adenocarcinoma

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria6

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

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Interventions

RADIATIONDose-Painted Intensity Modulated Radiotherapy

Fifteen fractions of external beam radiation therapy (EBRT) delivered via IMRT/ VMAT. Cohort 1 (n = 3-6) Single PTV 40.05 Gy/15#, homogenous dose. Cohort 2 (n = 3-6) High Risk PTV 45 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions. Cohort 3 (n = 3-6) High risk PTV 48 Gy/15# SIB to PTV tumour, Elective PTV 40.05 Gy/15# to nodal regions.