RecruitingPhase 2NCT03322995

Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial

Adaptive Modification of Neoadjuvant Therapy Based on Clinical Response in Patients With Localized Pancreatic Cancer


Sponsor

Medical College of Wisconsin

Enrollment

125 participants

Start Date

Jun 21, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, phase II study in patients with resectable and borderline resectable pancreas cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an adaptive chemotherapy approach for pancreatic cancer patients — adjusting or changing treatment regimens based on how well the tumour is responding before surgery, with the goal of shrinking the tumour enough to remove it completely. **You may be eligible if...** - You are 18 or older - You have been diagnosed with pancreatic cancer confirmed by a tissue sample - Your cancer is potentially removable by surgery - You are well enough to receive chemotherapy (ECOG performance status less than 2) - You are willing and able to give written consent **You may NOT be eligible if...** - Your cancer has spread widely and cannot be removed by surgery - You are not well enough for chemotherapy - You have already received treatment for this pancreatic cancer - You have serious organ problems that would prevent treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFirst-line Chemotherapy

The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.

DRUGSecond-line Chemotherapy

Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.

RADIATIONChemoradiation

50.4 Gy in 28 fractions.


Locations(1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT03322995


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