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

Phase 2

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: mFOLFIRINOX; Radiation: Stereotactic body radiotherapy (SBRT)

• Registration Number: NCT03991962
• Lead Sponsor: Yale University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2019-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-12
• Primary Completion: 2026-08
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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

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Exclusion Criteria

• Failing to meet any of the Inclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mFOLFIRINOX followed by SBRT	mFOLFIRINOX	Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).
mFOLFIRINOX followed by SBRT	Stereotactic body radiotherapy (SBRT)	Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	9 months	Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 3 years	Patients will be monitored for overall survival for up to 3 years depending on time when the initiation of treatment begins.
Radiographic Response	Within 21 days of starting study drug	Radiographic response to FOLFIRINOX and SBRT will be done by comparing IV contrast CT scans before and after therapy.
Rates of Recurrence	Up to 3 years	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.
Rates of grade 3 or greater gastrointestinal toxicity	Up to 3 months post treatment	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.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States