Adaptive radiation therapy for locally advanced, unresectable 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 single-center interventional study uses adaptive radiation therapy (ART) to personalize radiation delivery for patients with locally advanced, unresectable pancreatic ductal adenocarcinoma. Participants will undergo CT-based planning with possible placement of 1–3 small markers, a tumor biopsy, and serial blood draws, then receive five radiation treatments given every other day over two weeks. The protocol aims to adjust radiation targeting to concentrate dose on aggressive tumor areas while sparing surrounding healthy organs. Safety, feasibility, and preliminary signals of improved targeting and reduced toxicity will be recorded.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Patients must have histologically or cytologically-confirmed PDA.
2. Patients must have locally advanced unresectable PDA.

   • This includes the following- per NCCN criteria\*: 2.1 Unreconstructible involvement with the superior mesenteric vein or portal vein due to tumor or bland thrombus OR 2.2 Solid tumor contact with greater than 180 degrees of the superior mesenteric artery or celiac artery OR 2.3. Solid tumor contact with the aorta OR 2.4. Patients with non-metastatic disease that is inoperable by virtue of the operation posing excessive risk to the patient

   \*All patients must have been reviewed in the multidisciplinary conference and determined to have unresectable disease by a pancreatic surgeon and to have received or be ineligible for induction chemotherapy based on medical oncology assessment. Documentation of this review in EPIC meeting minutes will satisfy this requirement.
3. Patients enrolled onto the dose escalation arm may have started chemotherapy prior to initiation of radiation therapy and the last dose of chemotherapy must occur at least 2 weeks before start of ART.
4. Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
5. Adequate bone marrow, hepatic, renal function:

   * ANC ≥ 1,500/µl and PLT ≥ 100,000/µl
   * Bilirubin less than 1.5 ULN
   * AST and ALT \< 3X ULN
   * Serum Creatinine \<1.5X ULN
6. Women of childbearing potential must not be pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrheal and non-lactating for at least 12 months to be considered of non-childbearing potential. Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for at least 6 months after therapy is completed.
7. Age ≥ 18 years
8. Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment, tissue sample collections, and follow-up.

Exclusion Criteria

1. Radiologically or cytologically confirmed metastatic disease.
2. Patients who have had any prior radiation therapy for pancreatic cancer.
3. Patients who have had prior chemoradiation to an overlapping volume.
4. Patients with adenosquamous carcinoma of the pancreas.
5. Subjects who have had chemotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier to \< Grade 2. Patients who received previous immunotherapy or other antibody therapy, within 28 days (immune related toxicities must have resolved to \<= Grade 2 prior to starting treatment). Study treatment may be started within these washout periods or with continuing toxicities if considered by the Sponsor-Investigator to be safe and within the best interest of the patient.
6. Concurrent non-study chemotherapy or biologic therapy.
7. A history of ataxia telangiectasia or other documented history of radiation hypersensitivity.

   • Includes both bi- and mono-allelic likely pathogenic or pathogenic ATM mutations (VUS is acceptable).
8. Serious, active infections requiring treatment with IV antibiotics

Where it's running

• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Joshua Meyer, MD — Fox Chase Cancer Center
• Study coordinator: Joshua Meyer, MD
• Email: Joshua.Meyer@fccc.edu
• Phone: 215-728-2667

Similar studies

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

• Samuraciclib given before surgery or chemotherapy for certain pancreatic cancers

  This study tests whether taking samuraciclib before standard treatment is safe and helps patients with localized pancreatic cancer.

  Recruiting Phase 1 University of Washington · Seattle, Washington · NCT07645651

• PULSAR personalized ultrafractionated adaptive proton radiotherapy combined with systemic therapy for pancreatic cancer

  This trial will test whether personalized PULSAR proton radiotherapy given after initial chemotherapy can improve local control for people with borderline resectable, locally advanced, or limited metastatic pancreatic cancer.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Select Province/State · NCT07269626

• XER-001 (nasoduodenal amifostine) with SBRT for locally advanced pancreatic cancer

  This trial tests whether giving XER-001 through a nasoduodenal tube together with stereotactic body radiotherapy (SBRT) is safe and helpful for people with locally advanced pancreatic cancer.

  Recruiting at 5 sites Phase 1/2 Xerient Pharma · Duarte, California and 4 other locations · NCT07157033

• GnP plus serplulimab with stereotactic body radiation therapy for first-line locally advanced pancreatic cancer.

  This trial will test whether combining GnP chemotherapy, the immunotherapy serplulimab, and focused SBRT helps people aged 18–75 with untreated, locally advanced pancreatic ductal adenocarcinoma.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07101679

• OMO-103 for advanced or metastatic pancreatic ductal adenocarcinoma

  This trial tests an experimental IV drug called OMO-103 to see if it changes tumor cells in adults with locally advanced or metastatic pancreatic ductal adenocarcinoma.

  Recruiting Early Phase 1 OHSU Knight Cancer Institute · Portland, Oregon · NCT07089940

• Using advanced MRI to assess treatment response in pancreatic cancer

  This study is testing a new MRI technique to see if it can better predict how well treatment works for people with pancreatic cancer.

  Recruiting University of California, San Francisco · San Francisco, California · NCT06600906

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.