Clareo Health | Utilizing Standard of Care Induction Chemotherapy Followed by MR-LINAC Radiotherapy and Surgical Exploration to Improve Resectability Rates in Potentially Resectable Locally Advanced Pancreatic Cancer
Utilizing Standard of Care Induction Chemotherapy Followed by MR-LINAC Radiotherapy and Surgical Exploration to Improve Resectability Rates in Potentially Resectable Locally Advanced Pancreatic Cancer
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or female patients age 18 or older.
2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
3. Locally advanced, potentially resectable disease per ABC criteria after multidisciplinary review:
1. Anatomic: Tumor-artery contact \>180° but \<270° with the SMA or celiac, or ≤180° with mild contour irregularity but no frank stenosis; common hepatic artery (CHA) contact not reaching the celiac axis; venous involvement with a reconstructable SMV-PV segment.
2. Biologic: CA19-9 \< 600 U/mL (after biliary drainage if obstructed) and no evidence of radiographic/biochemical progression at baseline.
3. Conditional: ECOG 0-1, comorbidities optimized, albumin ≥ 3.0 g/dL.
4. No evidence of metastatic disease on staging imaging and laparoscopy.
4. Measurable or evaluable disease on pancreas-protocol CT or MRI (RECIST v1.1).
5. Adequate organ function, including all of the following (local lab ULN applied):
2. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if adequately stented); AST/ALT ≤ 2.5 × ULN.
3. Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault or equivalent).
6. ASA physical status I-III.
7. Life expectancy ≥ 12 weeks.
8. Able and willing to comply with study visits/procedures
9. Informed consent obtained; HIPAA authorization per institutional policy.
10. For participants of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception during protocol therapy and the specified post-therapy interval.
You may not be if
1. Patients age \< 18 or ≥ 90 years.
2. Metastatic disease on staging (distant organ or peritoneal metastases).
3. Disease meeting non-operative/unresectable ABC criteria, including any of the following:
* Anatomic: SMA encasement ≥ 270°; CHA involvement to the celiac origin/trifurcation; aortic invasion; no reconstructable SMV-PV segment; IVC invasion.
* Biologic: CA19-9 ≥ 600 U/mL (after biliary drainage if obstructed) or clear radiographic/biochemical progression prior to starting protocol therapy.
* Conditional: ECOG ≥ 2, ASA ≥ IV, or comorbidities that preclude major abdominal surgery despite optimization.
4. Prior radiotherapy to the pancreas or overlapping abdominal fields that would preclude protocol RT.
5. Prior pancreatic resection or local ablative therapy (e.g., IRE/RFA) to the primary tumor.
6. Prior systemic therapy for current LAPC (neoadjuvant/induction) before consent/enrollment.
7. Uncontrolled biliary obstruction not amenable to adequate drainage.
8. Active, uncontrolled infection or clinically significant cardiac, pulmonary, or hepatic disease that, in the investigator's judgment, poses unacceptable risk.
9. Contraindications to MRI/MR-guided therapy (e.g., non-MRI-compatible implants) or severe claustrophobia not manageable with standard measures.
10. Pregnant or breastfeeding individuals.
11. Known hypersensitivity to intended study medications or essential components of supportive care that cannot be mitigated.
12. Concurrent malignancy requiring active systemic treatment (except adequately treated non-melanoma skin cancer or in-situ cervical cancer).
13. Inability to provide informed consent or to comply with study procedures/assessments; absence of a legally authorized representative when needed.
14. Concurrent enrollment in another interventional clinical trial that, in the opinion of the investigator, could interfere with outcomes of this study.
