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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT03492671
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pancreas Adenocarcinoma
  • Resectable Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine 1000 mg — DRUG
    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)
  • nab-paclitaxel — DRUG
    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)
  • Stereotactic Body Radiation Therapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Jul 17, 2019
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy and SBRT
    Pre-Operative Chemotherapy: Within 28 days of study enrollment, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of four 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15. Post-Operative Chemotherapy: Within 5-10 weeks after surgery, subjects will receive a combination of Gemcitabine and Nab-paclitaxel for a maximum of two 28-day cycles. Gemcitabine 1000 mg/m2 IV on Days 1,8,15. Nab-paclitaxel 125 mg/m2 on Days 1,8,15. 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.

Primary Outcome Measure

Curative Intent Resection (R0) rate [ Time Frame: Within 2 weeks prior to initiation of post-operative chemotherapy. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University HealthLoma LindaCalifornia92354
Naveenraj Solomon, MD
[email protected]

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Loma Linda University Health· Loma Linda, CA

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