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

Yale University

Status and phase

Active, not recruiting

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: mFOLFIRINOX

Radiation: Stereotactic body radiotherapy (SBRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT03991962

2000024671

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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