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

NCT03492671 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: 5170277
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Adenocarcinoma; Resectable Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Curative Intent Resection (R0) rate

  Measure the rate of R0 resection with all margins microscopically clear.

  Within 2 weeks prior to initiation of post-operative chemotherapy.

Secondary Outcomes (2)

• Disease Free Survival Rate

  Every three months up to two years after resection.

• Overall Survival Rate

  Every six months up to 6 years post-resection.

Study Arms (1)

Chemotherapy and SBRT

EXPERIMENTAL

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.

Drug: Gemcitabine 1000 mg; Drug: nab-paclitaxel; Radiation: Stereotactic Body Radiation Therapy

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)

Chemotherapy and SBRT

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)

Chemotherapy and SBRT

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.

Also known as: SBRT

Chemotherapy and SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologic or histologic proof of adenocarcinoma of the pancreas.
• Localized, potentially resectable tumors.
• Greater or equal to 18 years of age.
• ECOG performance status of 0 or 1.
• Adequate hematologic, renal and hepatic function as defined by:
• ANC greater or equal to 1,500 cells/mm3
• Platelets greater or equal to 100,000 cells/mm3
• Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Serum creatinine ≤ 2 x ULN • ALT ≤ 5 x ULN
• AST ≤ 5 x ULN
• No history of prior therapy for pancreatic cancer.
• No history of active infection requiring IV antibiotics at the start of study treatment
• Non-pregnant and non-breast-feeding.

You may not qualify if:

• Patient has borderline resectable or metastatic disease.
• History of malignancy in the last 5 years other than in situ cancer or basal or squamous cell skin cancer or malignancies cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
• Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Naveenraj Solomon, MD

  Loma Linda University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naveenraj Solomon, MD

CONTACT

909-558-5498; nsolomon@llu.edu

Shagufta Shaheen, MD

CONTACT

909-558-4050; sshaheen@llu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: July 17, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)