RecruitingPhase 2NCT03492671

Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer

A Phase II Trial of Pre-operative Chemotherapy (With Gemcitabine and Nab- Paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients With Resectable Pancreatic Adenocarcinoma


Sponsor

Loma Linda University

Enrollment

30 participants

Start Date

Jul 17, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining two chemotherapy drugs (gemcitabine and nab-paclitaxel) with radiation therapy before surgery gives better results than current standard pre-surgery treatment in patients with localized, potentially removable pancreatic cancer. **You may be eligible if...** - You have been diagnosed with adenocarcinoma (the most common type) of the pancreas, confirmed by tissue or cell sampling - Your cancer is localized and potentially removable by surgery - You are 18 or older - You are in good overall health (ECOG 0 or 1 — able to perform normal activities) - You have not received any previous treatment for pancreatic cancer - Your blood counts, liver, and kidney function meet minimum requirements - You do not have an active serious infection **You may NOT be eligible if...** - Your cancer has spread to other organs (metastatic) or is considered borderline resectable (too close to major blood vessels) - You have had another cancer within the past 5 years (minor exceptions apply) - You have an active uncontrolled infection - You are pregnant or breastfeeding 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 1000 mg

Pre-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)

DRUGnab-paclitaxel

Pre-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)

RADIATIONStereotactic Body Radiation Therapy

Standard Stereotactic Body Radiation Therapy (SBRT) fractionation of 6 Gy per day will be used for all patients to a total dose of 30 Gy.


Locations(1)

Loma Linda University Health

Loma Linda, California, United States

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NCT03492671


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