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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.

Must not have

Patients with uncontrolled intercurrent illness or comorbidities that would prevent receipt of standard of care chemotherapy, radiation or surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any health conditions that would stop me from receiving standard cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measuring the proportion of patients undergoing surgical resection using historical data compared to 32 patients in current study.

Secondary study objectives

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.

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