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Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer (BCC-RAD-13)

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ClinicalTrials.gov Identifier: NCT02128100
Recruitment Status : Recruiting
First Posted : May 1, 2014
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Neal Edward Dunlap, University of Louisville

Brief Summary:
This study wants to find out how safe and effective the use of Folfirinox combined with Stereotactic Body Radiation Therapy )(SBRT) is for the treatment of pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Non-resectable Drug: Folfirinox Radiation: Stereotactic Body Radiation Therapy Phase 2

Detailed Description:
The study will be a prospective, non-randomized, single center, trial to assess the effects of FOLIRINOX chemotherapy with SBRT on locally advanced, non-resectable pancreatic cancer. Patients will either undergo a biopsy to confirm the diagnosis or have strong clinical suspicion of a new cancer or recurrence based on the recommendations of a multi-disciplinary GI oncology team. FOLFIRINOX with be delivered prior to SBRT for 4 cycles. Restaging imaging will occur prior to SBRT delivery. SBRT will be delivered using standard stereotactic techniques to a dose of 3200cGy at 650cGy per fraction delivered over 2 weeks. Additional adjuvant chemotherapy with be delivered at the physician's discretion. Patients will be reassessed both clinically and radiographically at 3 months, 6 months, 9 months and 12 months post-treatment. Quality of life analysis will occur at 3 month intervals after treatment. Blood will be drawn for exploratory biomarker analysis at strategic timepoints during treatment and followup. Following the initial imaging time points, standard surveillance will be employed with clinical assessment and imaging at 3 month intervals for the first 2 years post-treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of FOLFIRINOX and Stereotactic Body Radiation Therapy for Locally Advanced, Non-Resectable Pancreatic Cancer
Study Start Date : May 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Folririnox with SBRT

Folfirinox

  • Oxaliplatin 85 mg/m² for over 2 hours,
  • Leucovorin 400n mg/m² for over 2 hours,
  • Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion
  • Fluorouracil 400 mg/m² as a fast infusion over 15 minutes
  • Fluorouracil 2400 mg/m² as a slow infusion over 46 hours

SBRT 5 treatments of stereotactic body radiation therapy (SBRT) over the course of two weeks with a minimum of 36 hours in between each treatment.

Drug: Folfirinox
  • Oxaliplatin 85 mg/m² for over 2 hours,
  • Leucovorin 400n mg/m² for over 2 hours,
  • Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion
  • Fluorouracil 400 mg/m² as a fast infusion over 15 minutes
  • Fluorouracil 2400 mg/m² as a slow infusion over 46 hours
Other Names:
  • o Oxaliplatin
  • o Leucovorin
  • o Irinotecan
  • o Fluorouracil

Radiation: Stereotactic Body Radiation Therapy
5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment.




Primary Outcome Measures :
  1. Number of Participants with Adverse Event(s) as a Measure of Safety and Tolerability [ Time Frame: Assessed up to 24 months post treatment ]

Secondary Outcome Measures :
  1. Overall Response Rate for Participants [ Time Frame: Assessed at 3 months, 6 months, 9 months and 12 months post-treatment ]

Other Outcome Measures:
  1. Quality of Life Assessment [ Time Frame: Within 6 weeks of treatment and at 3 month intervals post-treatment up to 24 months. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/= 18 years
  • ECOG performance status 0-1
  • Pathologic or clinical diagnosis of a new pancreatic adenocarcinoma. A reasonable attempt should be made to make a pathologic diagnosis of malignancy.
  • Imaging as follows:

    • CT scan of the chest, abdomen and pelvis with IV and oral contrast within 8 weeks of registration
    • Whole body PET scan within 8 weeks of registration
  • Evaluation by a surgical oncologist to determine non-resectability
  • Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential.
  • CBC/differential obtained within 14 days prior to registration with adequate bone marrow function as follows:

    • ANC > 1,500 cell/mm3
    • Platelets > 100,000 cells/mm3
    • Hemoglobin > 8.0 g/dl (transfusion to obtain this value is permissible)
  • Additional labs within 14 days prior to registration

    • CA 19-9
    • Creatinine <2mg/dl
    • Bilirubin <2mg/dl
    • AST and ALT < 2.5 x ULN
  • Patients must provide study specific informed consent prior to study entry.

Exclusion Criteria:

  • Metastatic disease as defined by the multi-disciplinary team
  • Prior anti-cancer therapy for a pancreatic tumor
  • Prior malignancy within the last 3 years.
  • Pregnant women or lactating women
  • Acquired Immune Deficiency Syndrome (AIDS) based on CDC criteria. However HIV testing is not manditory for this protocol
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128100


Contacts
Contact: James Graham Brown Cancer Center 502-562-3429 aalutz01@louisville.edu

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Alicia A Lutz    502-562-3429    aalutz01@louisville.edu   
Sub-Investigator: Shiao Woo, MD         
Sub-Investigator: Craig Silverman, MD         
Sub-Investigator: Moataz El-Ghamry, MD         
Sub-Investigator: Vivek Sharma, MD         
Sub-Investigator: Rebecca Redman, MD         
Sub-Investigator: Charles Scoggins, MD         
Sub-Investigator: Robert Martin, MD         
James Graham Brown Cancer Center Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Alicia A Lutz    502-562-3429    aalutz@louisville.edu   
Principal Investigator: Neal E Dunlap, MD         
Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
Investigators
Principal Investigator: Neal E Dunlap, MD James Graham Brown Cancer Center

Responsible Party: Neal Edward Dunlap, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02128100     History of Changes
Other Study ID Numbers: BCC-RAD-13
IRB # 14.0XXX ( Other Identifier: UofL IRB )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by Neal Edward Dunlap, University of Louisville:
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Oxaliplatin
Irinotecan
Fluorouracil
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs