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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03991962
• Other study ID #: 2000024671
• Status: Recruiting
• Phase: Phase 2
• Start date: September 19, 2019
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Kimberly Johung, MD, PhD
• Phone: 203-737-6876
• Email: kimberly.johung[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Failing to meet any of the Inclusion Criteria

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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