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

NCT02128100 | Completed Phase 2 Results DMC

• 1 other identifier: 14.0413
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Non-resectable

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability

  Number of Participants With Grade 3 or Higher Adverse Event(s) as a Measure of Safety and Tolerability. This is based on CTCAE to assess toxicity at specified time points by the treating physician.

  Assessed up to 24 months post treatment

Secondary Outcomes (1)

• Overall Response Rate for Participants as Assessed by Contrast-enhanced CT Scan of the Abdomen at 12 Months.

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

Other Outcomes (1)

• Quality of Life Assessment at 12 Months Post-treatment

  12 months from completion of therapy

Study Arms (1)

Folririnox with SBRT

EXPERIMENTAL

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; Radiation: Stereotactic Body Radiation Therapy

Interventions

Folfirinox DRUG

* 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

Also known as: o Oxaliplatin, o Leucovorin, o Irinotecan, o Fluorouracil

Folririnox with SBRT

Stereotactic Body Radiation Therapy RADIATION

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

Folririnox with SBRT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox; 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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Neal Dunlap
• Organization: University of Louisville

neal.dunlap@louisville.edu

502-561-2700

Study Officials

• Neal E Dunlap, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: May 1, 2014
• Study Start: September 19, 2014
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-02

Locations

US (1)