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Anti-metabolites

Neoadjuvant Therapy for Pancreatic Cancer

Phase 2
Recruiting
Led By Davendra Sohal, Sohal
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years.
ECOG performance status ≤ 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing if a new cancer treatment can help people with pancreatic adenocarcinoma by increasing the rate at which the cancer can be surgically removed.

Who is the study for?
This trial is for adults with confirmed pancreatic carcinoma or adenocarcinoma who haven't had prior treatment for it. They must be in good health otherwise, not have other serious illnesses that could affect the study, and agree to use contraception. People with controlled HIV or cured hepatitis are eligible, but pregnant women and those unable to follow the study plan can't join.Check my eligibility
What is being tested?
The trial tests if neoadjuvant therapy (treatment given before main treatment) increases the chance of successfully removing pancreatic tumors through surgery. It involves a combination of chemotherapy drugs like Gemcitabine and Folfirinox, along with radiation therapy before a pancreatectomy.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, lowered blood cell counts leading to increased infection risk, hair loss from chemotherapy; skin irritation from radiation; and complications related to surgery such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I have not received any treatment for my pancreatic cancer.
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My diagnosis is pancreatic carcinoma or adenocarcinoma, confirmed by a tissue sample.
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My hepatitis B virus is under control with treatment.
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My tumor can possibly be removed with surgery, as determined by a scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Measuring the proportion of patients undergoing surgical resection using historical data compared to 32 patients in current study.
Secondary outcome measures
Measuring Disease-free survival after resection calculated as time from surgical resection to either disease recurrence or death, whichever comes first.
Measuring the Pathologic response to neoadjuvant therapy as Complete Response, Partial Response, Progressive Disease, or Stable Disease.
Measuring the Proportion of patients undergoing R0 resection, by Calculation of patients undergoing resection versus not able to undergo resection.
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neoadjuvant therapyExperimental Treatment4 Interventions
All patients will receive Neoadjuvant therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Gemcitabine
FDA approved
Pancreatectomy
2012
Completed Phase 2
~160
radiation therapy
1994
Completed Phase 3
~13390

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,362 Total Patients Enrolled
Davendra Sohal, SohalPrincipal Investigator - University of Cincinnati
University of Cincinnati Medical Center

Media Library

Folfirinox (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04594772 — Phase 2
Pancreatic Cancer Research Study Groups: Neoadjuvant therapy
Pancreatic Cancer Clinical Trial 2023: Folfirinox Highlights & Side Effects. Trial Name: NCT04594772 — Phase 2
Folfirinox (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04594772 — Phase 2

Frequently Asked Questions

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

Has the Folfirinox compound been granted sanction from the Food and Drug Administration?

"Taking into account the fact that Folfirinox is currently undergoing Phase 2 trials, our assessment of its safety was rated as a score of 2."

Answered by AI

Is the enrollment period of this trial still open?

"As per clinicaltrials.gov, this trial is actively recruiting potential candidates. This experiment was originally announced on March 17th 2021 and the details were last updated on September 13th 2022."

Answered by AI

Are there any other studies involving the therapeutic use of Folfirinox?

"Presently, 1585 medical studies are in progress that explore Folfirinox with 464 trials having reached Phase 3. The concentration of these investigations is most heavily concentrated in Guangzhou, Guangdong; however, 78235 sites around the world have launched their own clinical trails for this drug."

Answered by AI

To what extent has participation in this trial been successful?

"Affirmative, the information provided by clinicaltrials.gov verifies that this trial is presently recruiting participants. It was originally announced on March 17th 2021 and has recently been updated on September 13th 2022. 32 patients are required at two distinct locations for this research project to be successful."

Answered by AI

In what medical contexts is Folfirinox typically utilized?

"Folfirinox is commonly used to treat malignant neoplasms. Additionally, it can be beneficial for patients with non-small cell lung carcinoma, rectal carcinoma and colorectal carcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Adaptive Approach to Neoadjuvant Therapy to Maximize Resection Rates for Pancreatic Adenocarcinoma
Davendra Sohal 2021. "Adaptive Approach to Neoadjuvant Therapy to Maximize Resection Rates for Pancreatic Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04594772.
~0 spots leftby May 2024
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