Pancreatic CancerPhase 2NCT03991962
Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma
A Phase 2 study testing mFOLFIRINOX and Stereotactic body radiotherapy (SBRT) in people with Pancreatic Cancer, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- mFOLFIRINOX and Stereotactic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Failing to meet any of the Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06511
About this study
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- mFOLFIRINOX, Stereotactic body radiotherapy (SBRT)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFIRINOXDrug
Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks
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.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFIRINOX followed by SBRT | Experimental | Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT). Receives: Drug: mFOLFIRINOX; Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).
Measured: 9 months
Secondary outcomes (4)
Radiographic Response
Radiographic response to FOLFIRINOX and SBRT will be done by comparing IV contrast CT scans before and after therapy.
Measured: Within 21 days of starting study drug
Rates of Recurrence
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.
Measured: Up to 3 years
Rates of grade 3 or greater gastrointestinal toxicity
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.
Measured: Up to 3 months post treatment
Overall Survival
Patients will be monitored for overall survival for up to 3 years depending on time when the initiation of treatment begins.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start24 Sep 2019
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single group design
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Johung, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991962
- Sponsor's protocol ID
- 2000024671
- Status last verified
- Nov 2025
- First submitted
- 18 Jun 2019
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03991962
- Acronym / sponsor ID
- 2000024671
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single group design
| Arm | Type | Receives |
|---|---|---|
| mFOLFIRINOX followed by SBRT | Experimental | Drug: mFOLFIRINOX, Radiation: Stereotactic body radiotherapy (SBRT)Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (1 listed)
- Failing to meet any of the Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFIRINOXPatients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks | Drug | mFOLFIRINOX followed by SBRT |
| 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. | Radiation | mFOLFIRINOX followed by SBRT |
Primary outcome
Progression Free Survival
Time frame: 9 months
Progression-free survival (PFS) at will be judged by CT scan and Response evaluation criteria in solid tumors (RECIST).
4 secondary outcomes
Radiographic Response
Time frame: Within 21 days of starting study drug
Rates of Recurrence
Time frame: Up to 3 years
Rates of grade 3 or greater gastrointestinal toxicity
Time frame: Up to 3 months post treatment
Overall Survival
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Johung, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFIRINOX and Stereotactic body radiotherapy (SBRT) in people with Pancreatic Cancer, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.