SMART-PANC Trial: Personalized Treatment for Resectable and Borderline Resectable Pancreatic Cancer

Sponsor: Northwestern University

Sponsor score: 0

ClinicalTrials ID:NCT07748611

Provider View

This study is exploring a personalized approach to chemotherapy for patients with pancreatic cancer that can be surgically removed or is borderline resectable. By focusing on a specific genetic marker, SMAD4, the trial aims to improve treatment outcomes.

Patient Parameters

Program Overview

This Phase II trial is testing a personalized chemotherapy approach for patients with pancreatic ductal adenocarcinoma (PDAC) that can be surgically removed or is borderline resectable. PDAC is a fast-growing and aggressive cancer. The study focuses on the SMAD4 gene, which normally helps control cell growth. When this gene is mutated, the cancer becomes more aggressive and resistant to standard treatments. By tailoring chemotherapy based on the SMAD4 mutation, the study aims to improve surgical outcomes and overall treatment success.

Description

Primary Objective:

  • To find out how many patients with SMAD4-mutant pancreatic cancer can have successful surgery after receiving gemcitabine and nab-paclitaxel (Cohort A).

Secondary Objectives:

  • To see how many patients agree to join the study, aiming for at least 70% participation.
  • To find out how many patients with SMAD4 wild-type cancer can have successful surgery after receiving a chemotherapy chosen by their doctor (Cohort B).
  • To measure how well the cancer responds to treatment before surgery.
  • To track how long patients live without the cancer getting worse (progression-free survival) and overall survival.

Exploratory Objectives:

  • To compare surgery success rates between patients with SMAD4 mutations and those without.
  • To study changes in cancer markers in the blood before and after treatment.
  • To understand why some patients cannot have surgery, such as worsening health or cancer spread.

Study Outline:

  • Cohort A: Patients with SMAD4 mutations receive gemcitabine and nab-paclitaxel, possibly with radiation. Treatment lasts 8 weeks, with possible extensions. Surgery follows 21 days after the last chemotherapy dose.
  • Cohort B: Patients without SMAD4 mutations receive a chemotherapy chosen by their doctor, possibly with radiation. Treatment lasts 8 weeks, with possible extensions. Surgery follows 21 days after the last chemotherapy dose.

Patients will have regular blood tests and scans throughout the study. After treatment, follow-ups occur 30 days post-surgery and every 3 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed pancreatic ductal adenocarcinoma.
  • Recent imaging must show no cancer spread beyond the pancreas.
  • Must have genetic testing showing SMAD4 mutation or not.
  • Cancer must be resectable or borderline resectable.
  • Must not have had previous treatment for this cancer.
  • Must be 18 years or older.
  • Must be in good health with an ECOG score of 0-1.
  • Must have good organ and bone marrow function.
  • Must agree to use effective birth control during the study.
  • Must have a negative pregnancy test if applicable.
  • Must understand and agree to the study requirements.

Exclusion Criteria

  • Cannot have certain genetic conditions like Lynch syndrome or high microsatellite instability.
  • Cannot be in another study with a different drug.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have another cancer that could interfere with this study.
  • Cannot be pregnant or breastfeeding.
  • Cannot have uncontrolled health issues like high blood pressure or infections.
  • Cannot have any condition that would make participating unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
Northwestern University60611ChicagoIllinois

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