RecruitingPhase 1Phase 2NCT03652428

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

Phase I Study of Concurrent Nab-Paclitaxel + Gemcitabine With Hypofractionated, Ablative Proton Therapy for Locally Advanced Pancreatic Cancer


Sponsor

University of Maryland, Baltimore

Enrollment

24 participants

Start Date

Apr 2, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Friday) for 3 weeks. Participants will also receive chemotherapy on each Monday of those three weeks.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether combining two chemotherapy drugs (nab-paclitaxel and gemcitabine) with proton radiation therapy is safe and effective for patients with pancreatic cancer that cannot be surgically removed but has not yet spread to distant organs. **You may be eligible if...** - You have been diagnosed with pancreatic cancer (adenocarcinoma) confirmed by biopsy or fluid test - Your cancer has not spread to distant organs (non-metastatic) - Imaging shows the cancer cannot be surgically removed at this time - You are in good overall health - You are 18 years old or older **You may NOT be eligible if...** - Your cancer has already spread to distant organs, lymph nodes outside the region, the lining of the abdomen, or caused fluid buildup in the belly - You have had prior radiation to the stomach area - You have serious heart or liver problems - You are pregnant or breastfeeding - You have had prior chemotherapy for this cancer (in some study phases) 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

DRUGGemcitabine

see arm description

RADIATIONHypofractionated Ablative Proton Therapy

see arm description


Locations(2)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

University of Maryland Medical Center/Maryland Proton Treatment Center

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT03652428


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