Phase II Study To Evaluate Modified Folfirinox And Stereotactic Body Radiation Therapy In Non-metastatic Unresectable Pancreatic Adenocarcinoma

Study Overview

Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the efficacy of modified FOLFIRINOX followed by stereotactic body radiotherapy (SBRT) in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). The primary hypothesis will be to determine if modified FOLFIRINOX followed by SBRT improves progression free survival (PFS) compared to historical controls treated with gemcitabine-based chemotherapy with or without standard fractionated radiation.

The Primary and Secondary are listed below. Primary Objective: - To evaluate progression free survival after modified FOLFIRINOX and SBRT in borderline resectable and locally advanced pancreatic cancer. Secondary Objective: * To evaluate the radiographic response to FOLFIRINOX and SBRT by comparing IV contrast CT scans before and after therapy. * To determine rates of recurrence (local only, systemic only, and both local and systemic), and overall survival. * To determine rates of grade 3 or greater gastrointestinal toxicity, including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.

Pancreatic Cancer

DRUG: mFOLFIRINOX
RADIATION: Stereotactic body radiotherapy (SBRT)

2000024671

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	Results Reporting Dates	Study Record Updates
First Submitted 2019-06-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-07
First Submitted that Met QC Criteria 2019-06-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-12
First Posted (ACTUAL) 2019-06-19	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: mFOLFIRINOX followed by SBRT Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).	DRUG: mFOLFIRINOX Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks RADIATION: Stereotactic body radiotherapy (SBRT) Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved lymph nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: mFOLFIRINOX followed by SBRT

Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).

DRUG: mFOLFIRINOX

Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks

RADIATION: Stereotactic body radiotherapy (SBRT)

Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved lymph nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.

Primary Outcome Measures	Measure Description	Time Frame
Progression Free Survival	Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).	9 months

Secondary Outcome Measures	Measure Description	Time Frame
Radiographic Response	Radiographic response to FOLFIRINOX and SBRT will be done by comparing IV contrast CT scans before and after therapy.	Within 21 days of starting study drug
Rates of Recurrence	Rates of recurrence (local only, systemic only, and both local and systemic) will be monitored for up to 3 years depending on time when the initiation of treatment begins.	Up to 3 years
Rates of grade 3 or greater gastrointestinal toxicity	Grade 3 or greater gastrointestinal toxicities will be monitored including acute toxicities occurring within 3 months of treatment, and late toxicities occurring over 3 months after completion of radiation.	Up to 3 months post treatment
Overall Survival	Patients will be monitored for overall survival for up to 3 years depending on time when the initiation of treatment begins.	Up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Kimberly Johung, MD, PhD

Phone Number: 203-737-6876

Email: kimberly.johung@yale.edu

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed pancreatic adenocarcinoma
Borderline resectable pancreatic adenocarcinoma or locally advanced pancreatic adenocarcinoma
No evidence of extrapancreatic disease on diagnostic imaging
No evidence of invasion into the duodenum or stomach, as determined by EGD/EUS
No prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer
No prior treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine
ECOG Performance Status of 0-1
No other malignancy within past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer)
No evidence of second malignancy at the time of study entry
No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
No > grade 2 sensory peripheral neuropathy
No uncontrolled seizure disorder, active neurological disease, or known CNS disease
No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
Not pregnant and not nursing
No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
Laboratory parameters as follows:

Absolute neutrophil count ≥1,500/uL,
Platelet count ≥75,000/uL,
Hemoglobin ≥9 g,/dL,
Creatinine <1.5 X ULN or estimated GFR >30 ml/min,
Bilirubin <1.5 X ULN,
AST and ALT <3 X ULN,
Negative pregnancy test in women of childbearing potential
Able to be treated with SBRT only at the Smilow New Haven campus
Able to have fiducials placed in the pancreas

Failing to meet any of the Inclusion Criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Kimberly Johung, MD, PhD, Yale University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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