Study on Alternating Chemotherapy Treatments for Borderline Resectable Pancreatic Cancer

Sponsor: Dartmouth-Hitchcock Medical Center

Sponsor score: 0

ClinicalTrials ID:NCT07043270

Provider View

This clinical trial is exploring the effects and safety of alternating two chemotherapy treatments for patients with borderline resectable pancreatic cancer, aiming to improve treatment outcomes and reduce the risk of cancer returning.

Patient Parameters

Program Overview

The study is testing two chemotherapy treatments, mFOLFIRINOX and gemcitabine plus nab-paclitaxel (GnP), which are already approved for treating borderline resectable pancreatic cancer. By alternating these treatments, researchers hope to enhance the response to therapy, make tumors easier to remove surgically, and lower the chances of the cancer coming back.

Description

This clinical trial involves alternating two chemotherapy treatments, mFOLFIRINOX and GnP, for patients with borderline resectable pancreatic cancer. Both treatments are approved by the FDA and are commonly used. The goal is to see if switching between these treatments can improve how well the cancer responds, make it easier to remove the tumor surgically, and reduce the risk of the cancer returning. Participants will receive these treatments before surgery, which is known as neoadjuvant chemotherapy. The study aims to provide insights into whether this alternating approach can offer better outcomes for patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with borderline resectable pancreatic cancer, confirmed by a team of specialists at the Dartmouth Cancer Center.
  • Must be able and willing to give informed consent to participate in the study.
  • Must have had a CT scan of the chest, abdomen, and pelvis within 45 days before joining the study.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can carry out light work.
  • Women who can become pregnant must have a negative pregnancy test within 14 days before joining the study and agree to use effective birth control during the treatment.

Exclusion Criteria

  • Have received chemotherapy or radiation therapy for pancreatic cancer before.
  • Have a specific genetic condition known as DPYD poor metabolizer genotype.
  • Have known mutations in BRCA1/2 or PALB2 genes. If these mutations are found after joining the study, the participant will be removed from the study treatment.
  • Have another cancer that is likely to need treatment during the study.
  • Have certain blood or liver test results outside the normal range, such as low blood cell counts or high liver enzymes.
  • Have nerve damage that affects daily activities.
  • Are unable to provide informed consent.
  • Are pregnant or breastfeeding.
  • Are currently in prison.

Locations

FACILITYZIPCITYSTATE
Dartmouth-Hitchcock Medical Center03756LebanonNew Hampshire

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