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New treatment option for Pancreatic Adenocarcinoma
Official title Dose-Painted Intensity Modulated Radiotherapy Pancreas (DP-IMRT Pancreas)
ClinicalTrials.gov ID: NCT06024824
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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)...
- 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...
- Evidence of any other significant clinical disorder or laboratory findings that makes it undesirable for the patient to participate in the study, or...
See the full eligibility 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dublin, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dublin, Ireland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.