SMAD4 Tailored Neoadjuvant Therapy for the Treatment of Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma, SMART-PANC Trial

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07748611
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Borderline Resectable Pancreatic Ductal Adenocarcinoma
  • Resectable Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Fluorouracil — DRUG
    Given fluorouracil
  • Gemcitabine — DRUG
    Given gemcitabine
  • Irinotecan — DRUG
    Given irinotecan
  • Leucovorin — DRUG
    Given leucovorin
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nab-paclitaxel — DRUG
    Given nab-paclitaxel
  • Oxaliplatin — DRUG
    Given oxaliplatin
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Surgical Procedure — PROCEDURE
    Undergo surgical resection

Study Details

This phase II trial tests the impact of using SMAD4-mutant status to personalize chemotherapy in treating patients with pancreatic ductal adenocarcinoma (PDAC) that can be removed by surgery (resectable) or that may be between resectable and unresectable (borderline resectable) before undergoing surgery (neoadjuvant). PDAC is one of the most aggressive and fastest growing tumors. SMAD4, a tumor suppressor gene, acts like a brake on cell growth and helps to prevent tumor cells from growing. However, losing it makes the tumor more aggressive and often resistant to standard of care (SOC) treatments regimens, such as gemcitabine with nab-paclitaxel and fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic (DNA) and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Instead of a one-sized fits all treatment approach with SOC therapies, matching therapy based on SMAD4 mutation status may use this specific genetic weakness against the tumor. This approach to neoadjuvant therapy may dramatically alter the path of treatment and improve outcomes, including complete resection rates, in patients with resectable or borderline resectable PDAC.

Key Dates

First listed
Aug 6, 2026
Start date
Feb 3, 2027
Status verified
Jul 2026
Primary completion
Feb 3, 2030
Completion
Feb 3, 2031

Study Design

Enrollment
125 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (gemcitabine, nab-paclitaxel)
    Patients receive gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study.
  • Experimental: Cohort B (gemcitabine, nab-paclitaxel or FOLFIRINOX)
    Patients receive either physicians choice of either fluorouracil, leucovorin, irinotecan, and oxaliplatin or gemcitabine and nab-paclitaxel with or without radiation therapy per SOC. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. After 8 week restaging, patients may continue to receive treatment for up to 16 or 24 weeks at the discretion of the multidisciplinary tumor board. Starting 21 days after last dose of chemotherapy, patients undergo surgical resection. Additionally, patients undergo blood sample collection and CT or MRI as clinically indicated throughout the study.

Primary Outcome Measure

Proportion of patients who achieve R0/R1 surgical resection (Cohort A) [ Time Frame: Up to 30 days from surgical resection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Brett L. Ecker, MD
[email protected]
Brett L. Ecker, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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