Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma
NCT ID: NCT03991962
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2019-09-19
2027-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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mFOLFIRINOX followed by SBRT
Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).
mFOLFIRINOX
Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks
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.
Interventions
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mFOLFIRINOX
Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Kimberly Johung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Kimberly Johung, MD, PhD
Role: primary
Kwasi Boateng, MS
Role: backup
Other Identifiers
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2000024671
Identifier Type: -
Identifier Source: org_study_id