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

Primary Purpose

Pancreatic Cancer Non-resectable

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Folfirinox

Stereotactic Body Radiation Therapy

About this trial

This is an interventional treatment trial for Pancreatic Cancer Non-resectable focused on measuring Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

James Graham Brown Cancer CenterRecruiting
James Graham Brown Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Folririnox with SBRT

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Event(s) as a Measure of Safety and Tolerability

Secondary Outcome Measures

Overall Response Rate for Participants

Full Information

NCT ID

NCT02128100

First Posted

April 22, 2014

Last Updated

October 24, 2019

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02128100

Brief Title

Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer

Acronym

BCC-RAD-13

Official Title

The Effect of FOLFIRINOX and Stereotactic Body Radiation Therapy for Locally Advanced, Non-Resectable Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Recruiting

Study Start Date

May 2014 (undefined)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer Non-resectable

Keywords

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Folririnox with SBRT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Folfirinox

Other Intervention Name(s)

o Oxaliplatin, o Leucovorin, o Irinotecan, o Fluorouracil

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

Overall Response Rate for Participants

Time Frame

Assessed at 3 months, 6 months, 9 months and 12 months post-treatment

Other Pre-specified Outcome Measures:

Title

Quality of Life Assessment

Time Frame

Within 6 weeks of treatment and at 3 month intervals post-treatment up to 24 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James Graham Brown Cancer Center

Phone

502-562-3429

aalutz01@louisville.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neal E Dunlap, MD

Organizational Affiliation

James Graham Brown Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

James Graham Brown Cancer Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alicia A Lutz

Phone

502-562-3429

aalutz01@louisville.edu

First Name & Middle Initial & Last Name & Degree

Shiao Woo, MD

First Name & Middle Initial & Last Name & Degree

Craig Silverman, MD

First Name & Middle Initial & Last Name & Degree

Moataz El-Ghamry, MD

First Name & Middle Initial & Last Name & Degree

Vivek Sharma, MD

First Name & Middle Initial & Last Name & Degree

Rebecca Redman, MD

First Name & Middle Initial & Last Name & Degree

Charles Scoggins, MD

First Name & Middle Initial & Last Name & Degree

Robert Martin, MD

Facility Name

James Graham Brown Cancer Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alicia A Lutz

Phone

502-562-3429

aalutz@louisville.edu

First Name & Middle Initial & Last Name & Degree

Neal E Dunlap, MD

12. IPD Sharing Statement

Learn more about this trial

Effects of Folfirinox and Stereotactic Body Radiation Therapy for Advanced Pancreatic Cancer

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