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Chemotherapy

Chemotherapy + SBRT for Pancreatic Cancer

Phase 2

Recruiting

Led By Kimberly Johung, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer

Borderline resectable pancreatic adenocarcinoma or locally advanced pancreatic adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial will compare a new chemotherapy treatment for pancreatic cancer to standard care. The new treatment consists of modified FOLFIRINOX followed by SBRT. The primary hypothesis is that the new treatment will improve progression free survival.

Who is the study for?

This trial is for adults with non-metastatic, unresectable pancreatic adenocarcinoma who haven't had prior treatments. They should be in good physical condition (ECOG 0-1), not pregnant or nursing, and have adequate blood counts and organ function. Those with recent heart issues, other cancers within five years (with some exceptions), or significant lung disease can't participate.Check my eligibility

What is being tested?

The study tests if a chemotherapy combo called modified FOLFIRINOX followed by targeted radiation therapy (SBRT) can improve the time patients live without their cancer getting worse compared to previous standard treatments. It's specifically for those with borderline resectable or locally advanced pancreatic cancer.See study design

What are the potential side effects?

Modified FOLFIRINOX may cause side effects like nausea, diarrhea, low blood cell counts increasing infection risk, fatigue, and nerve damage. SBRT might lead to abdominal pain or discomfort due to its focused high-dose radiation targeting the tumor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not received any treatment for pancreatic cancer.

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My pancreatic cancer is at a stage where surgery might be possible.

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I do not have severe numbness or pain in my hands or feet.

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My kidney function is within the required range.

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I am fully active or can carry out light work.

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My cancer is a type of pancreatic cancer confirmed by tissue analysis.

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I do not have any other type of cancer.

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I can receive SBRT treatment at the Smilow New Haven campus.

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I can have markers placed in my pancreas for treatment.

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I do not have serious heart problems like recent heart attacks or severe heart failure.

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I do not have uncontrolled seizures or active brain diseases.

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I do not have lung fibrosis or pneumonia.

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I have not been treated with oxaliplatin, irinotecan, fluorouracil, or capecitabine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival

Secondary outcome measures

Overall Survival

Radiographic Response

Rates of Recurrence

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: mFOLFIRINOX followed by SBRTExperimental Treatment2 Interventions

Patients will receive mFOLFIRINOX, followed stereotactic body radiotherapy (SBRT).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic body radiotherapy (SBRT)

2018

Completed Phase 1

~80

mFOLFIRINOX

2013

Completed Phase 2

~40

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,854 Previous Clinical Trials

2,740,533 Total Patients Enrolled

Kimberly Johung, MD, PhDPrincipal InvestigatorYale University

1 Previous Clinical Trials

9 Total Patients Enrolled

Media Library

mFOLFIRINOX (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03991962 — Phase 2

Pancreatic Cancer Research Study Groups: mFOLFIRINOX followed by SBRT

Pancreatic Cancer Clinical Trial 2023: mFOLFIRINOX Highlights & Side Effects. Trial Name: NCT03991962 — Phase 2

mFOLFIRINOX (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03991962 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can this trial accommodate?

"Affirmative. Clinicaltrials.gov's listing reflects that this experiment is actively recruiting volunteers, having first gone live on September 19th 2019 and been recently edited on the 14th of September 2022. The trial requires 28 participants from a single clinical centre."

Answered by AI

What are the safety implications of Stereotactic body radiotherapy (SBRT) for individuals?

"SBRT has been rated a 2 on our 1-3 scale due to the data gathered during its Phase 2 trials, which suggest that it is safe but not yet efficacious."

Answered by AI

Are there vacancies available for potential participants in this research trial?

"Affirmative. Clinicaltrials.gov presents evidence that this clinical trial is actively searching for volunteers; the study has been live since September 19th 2019 and was recently modified on September 14th 2022. The research team seeks 28 individuals at one medical centre to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03991962.