Clinical trial NCT03991962: Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma
Official title: Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single group design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 9 months
Secondary outcomes:
measure: Radiographic Response
timeFrame: Within 21 days of starting study drug
measure: Rates of Recurrence
timeFrame: Up to 3 years
measure: Rates of grade 3 or greater gastrointestinal toxicity
timeFrame: Up to 3 months post treatment
measure: Overall Survival
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly Johung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: