Dose-Painted Intensity Modulated Radiotherapy for Pancreatic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of dose-painted intensity modulated radiotherapy (DP-IMRT) for patients with resectable or borderline resectable pancreatic adenocarcinoma. It employs a dose escalation approach, where patients receive increasing doses of radiotherapy based on their tolerance to the treatment, starting from a standard care dose. The study aims to establish the maximum tolerated dose (MTD) in Phase I, followed by a larger cohort receiving this optimized dose in Phase II. The trial includes comprehensive imaging to confirm the absence of metastatic disease before treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• St Luke's Radiation Oncology Network (SLRON)
  Dublin, Ireland Recruiting
• St Vincent's University Hospital
  Dublin, Ireland Recruiting

Study contacts

• Study coordinator: Cancer Trials Ireland
• Email: info@cancertrials.ie
• Phone: +35316677211

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zoldonrasib plus Daraxonrasib vs Gemcitabine and Nab-Paclitaxel as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This study tests whether two investigational RAS inhibitors together can improve outcomes compared with standard chemotherapy in adults with newly diagnosed metastatic pancreatic cancer carrying the KRAS G12D mutation.

  Recruiting at 6 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 5 other locations · NCT07805954

• XYA02 in advanced solid tumors

  This trial tests XYA02 in adults with MUC1-expressing advanced or relapsed solid tumors to see if it is safe, tolerable, and can shrink tumors.

  Recruiting at 2 sites Phase 1/2 XYone Therapeutics, Inc · Sydney, New South Wales and 4 other locations · NCT07670312

• Zoldonrasib + chemotherapy vs placebo + chemotherapy as first-line treatment for metastatic KRAS G12D pancreatic cancer

  This trial tests whether adding zoldonrasib to standard chemotherapy helps people with newly diagnosed metastatic KRAS G12D pancreatic cancer.

  Recruiting at 25 sites Phase 3 Revolution Medicines, Inc. · Phoenix, Arizona and 24 other locations · NCT07621718

• MyCap app to track time burden of pancreatic cancer treatment

  This study tests whether a mobile app can help adults with pancreatic cancer log the time they spend on cancer care.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07619391

• KRAS G12V cancer patients get TCR1188-ABC cell therapy

  This early-phase trial tests whether TCR1188-ABC cells can safely be given to adults with KRAS G12V-mutated metastatic cancers to see if it can help some types of pancreatic, biliary, colorectal, or lung cancer.

  Recruiting Phase 1 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07594067

• Lorigerlimab in pancreatic cancer with BRCA/RAD51 gene mutations

  This phase 2 study tests Lorigerlimab in adults with metastatic pancreatic cancer who have BRCA1/2, PALB2, RAD51C, or RAD51D germline mutations.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT07565155

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.