24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

NCT07043270 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: STUDY0200268124BRO681NCI-2022-08163
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.

Conditions

Pancreas Adenocarcinoma

Keywords

mFOLFIRINOX; Gemcitabine; Nab-Paclitaxel; Neoadjuvant alternating chemotherapy; Resectable Pancreatic cancer; BR-PDAC; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• One-year event-free survival (1y-EFS)

  One-year EFS is defined as completing one year from enrollment without the occurrence of any of the following events: 1) disease progression per Response Evaluation Criteria in Solid Tumors (RECIST), 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death from any cause.

  I year

Secondary Outcomes (9)

• Proportion of patients who complete the study intervention

  1 year

• Proportion of patients who require dose modification

  1 year

• Proportion of patients who undergo surgery

  1 year

• Radiographic response (unconfirmed) after chemotherapy, per RECIST

  1 year

• Surgical resection rate (R0, R1 and R2 resection)

  1 year

Study Arms (1)

Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX

EXPERIMENTAL

Patient has been diagnosed with borderline resectable pancreatic ductal adenocarcinoma (pancreatic cancer) and has not received systemic or radiation therapy. Treating physician has recommended neoadjuvant (pre-operative) chemotherapy and radiation, prior to surgery.

Drug: Nab-paclitaxel + Gemcitabine; Drug: modified FOLFIRINOX (mFOLFIRINOX)

Interventions

Nab-paclitaxel + Gemcitabine DRUG

Administered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles).

Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX

modified FOLFIRINOX (mFOLFIRINOX) DRUG

Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles).

Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of BR-PDAC. The resectability should be officially determined with surgical oncologists at the Dartmouth Cancer Center (DCC) GI multidisciplinary Tumor Board based on NCCN Guidelines Version 2.2024 Pancreatic Adenocarcinoma.
• Patients must be able and willing to provide informed consent.
• Contrast-enhanced CT scan of the chest, abdomen, and pelvis performed within 45 days before registration.
• ECOG Performance Status: 0-1.
• Females of childbearing potential must have a negative pregnancy test done ≤ 14 days prior to study enrollment, and must agree to use a highly effective method of contraception throughout the course of protocol therapy.

You may not qualify if:

• Any prior receipt of chemotherapy or radiation therapy for PDAC.
• Known DPYD poor metabolizer genotype.
• Any confirmed second malignancy that is likely to require systemic therapy during the study period, in the opinion of the enrolling investigator.
• Any of the following baseline laboratory abnormalities:
• Absolute neutrophil count (ANC) \< 2,500/mm3
• Platelet count \< 100,000/mm3
• Hemoglobin \< 7 g/dL
• Creatinine \> 1.5 x upper limit of normal (ULN)
• Total bilirubin \> 1.5 x ULN
• AST/ALT \> 5 x ULN
• Any peripheral sensory neuropathy that meaningfully impairs performance of instrumental activities of daily living, as evaluated by the enrolling investigator.
• Patients who are unable to provide informed consent.
• Patients who are pregnant or breastfeeding.
• Patients who are incarcerated.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Cancer Research Nurse

CONTACT

800-639-6918; cancer.research.nurse@hitchcock.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single site, single-arm, open-label prospective clinical trial of the alternating GnP and mFOLFIRINOX regimens in selected patients with borderline-resectable pancreatic ductal adenocarcinoma (BR-PDAC) who have not received previous systemic or radiation therapy forPDAC.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 29, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-05

Locations

US (1)