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

NCT03991962 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2000024671
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Radiographic Response

  Within 21 days of starting study drug

• Rates of Recurrence

  Up to 3 years

• Rates of grade 3 or greater gastrointestinal toxicity

  Up to 3 months post treatment

• Overall Survival

  Up to 3 years

Study Arms (1)

mFOLFIRINOX followed by SBRT

EXPERIMENTAL

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

Drug: mFOLFIRINOX; Radiation: Stereotactic body radiotherapy (SBRT)

Interventions

mFOLFIRINOX DRUG

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

mFOLFIRINOX followed by SBRT

Stereotactic body radiotherapy (SBRT) RADIATION

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.

mFOLFIRINOX followed by SBRT

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

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

Study Officials

• Kimberly Johung, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single group design

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 19, 2019
• Study Start: September 24, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)