RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-07-17
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03492671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Patient has borderline resectable or metastatic disease.
  2. * 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.
  3. * Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

Contacts and Locations

Study Contact

Naveenraj Solomon, MD
CONTACT
909-558-5498
nsolomon@llu.edu
Shagufta Shaheen, MD
CONTACT
909-558-4050
sshaheen@llu.edu

Principal Investigator

Naveenraj Solomon, MD
PRINCIPAL_INVESTIGATOR
Loma Linda University Cancer Center

Study Locations (Sites)

Loma Linda University Health
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Naveenraj Solomon, MD, PRINCIPAL_INVESTIGATOR, Loma Linda University Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-17
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2019-07-17
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Pancreatic Cancer

Additional Relevant MeSH Terms

  • Pancreas Adenocarcinoma
  • Resectable Pancreatic Cancer