Pancreas AdenocarcinomaPhase 2NCT07043270
24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC
A Phase 2 study testing Nab-paclitaxel + Gemcitabine and modified FOLFIRINOX (mFOLFIRINOX) in people with Pancreas Adenocarcinoma, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma
- What is being tested?
- Nab-paclitaxel + Gemcitabine and modified FOLFIRINOX (mFOLFIRINOX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 1 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any prior receipt of chemotherapy or radiation therapy for PDAC.
- Known DPYD poor metabolizer genotype.
- Known BRCA1/2 or PALB2 mutations. If they are found to have BRCA1/2 or PALB2 mutation after inclusion to the trial, the participant will be taken off of protocol therapy (since platinum-containing therapy is preferred for these patients).
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: 24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
Read the detailed description
Modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) are two of the preferred chemotherapy treatments at this time. The U.S. Food and Drug Administration (FDA) has approved each of these treatments for patients with borderline resectable pancreatic cancer. This study will alternate these two neoadjuvant chemotherapy treatments (GnP and mFOLFIRINOX). The study doctors hope that alternating these treatments may improve the treatment response, improve tumor removal (also called "resectability"), and lower the risk of cancer coming back.
- Conditions
- Pancreas Adenocarcinoma
- Being tested
- Nab-paclitaxel + Gemcitabine, modified FOLFIRINOX (mFOLFIRINOX)
- Keywords
- mFOLFIRINOX, Gemcitabine, Nab-Paclitaxel, Neoadjuvant alternating chemotherapy, Resectable Pancreatic cancer, BR-PDAC, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxel + GemcitabineDrug
Administered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles).
modified FOLFIRINOX (mFOLFIRINOX)Drug
Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nab-paclitaxel + Gemcitabine; Drug: modified FOLFIRINOX (mFOLFIRINOX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: I year
Secondary outcomes (9)
Proportion of patients who complete the study intervention
Measured: 1 year
Proportion of patients who require dose modification
Measured: 1 year
Proportion of patients who undergo surgery
Measured: 1 year
Radiographic response (unconfirmed) after chemotherapy, per RECIST
Measured: 1 year
Surgical resection rate (R0, R1 and R2 resection)
Measured: 1 year
Pathologic response observed in the surgical specimen
Measured: 1 year
Recurrence-free survival (RFS) in patients who undergo surgery
Measured: 1 year
EFS (Event Free Survival) and OS (Overall Survival)
Measured: 1 year
Trend of CA19-9
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start29 Sep 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel A. Brooks, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043270
- Sponsor's protocol ID
- STUDY02002681
- Other IDs
- 24BRO681, NCI-2022-08163
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT07043270
- Acronym / sponsor ID
- STUDY02002681
- Conditions
- Pancreas Adenocarcinoma
- Keywords
- mFOLFIRINOX, Gemcitabine, Nab-Paclitaxel, Neoadjuvant alternating chemotherapy, Resectable Pancreatic cancer, BR-PDAC, Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
Detailed description
Modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine plus nab-paclitaxel (GnP) are two of the preferred chemotherapy treatments at this time. The U.S. Food and Drug Administration (FDA) has approved each of these treatments for patients with borderline resectable pancreatic cancer. This study will alternate these two neoadjuvant chemotherapy treatments (GnP and mFOLFIRINOX). The study doctors hope that alternating these treatments may improve the treatment response, improve tumor removal (also called "resectability"), and lower the risk of cancer coming back.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX | Experimental | Drug: Nab-paclitaxel + Gemcitabine, Drug: modified FOLFIRINOX (mFOLFIRINOX)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- Any prior receipt of chemotherapy or radiation therapy for PDAC.
- Known DPYD poor metabolizer genotype.
- Known BRCA1/2 or PALB2 mutations. If they are found to have BRCA1/2 or PALB2 mutation after inclusion to the trial, the participant will be taken off of protocol therapy (since platinum-containing therapy is preferred for these patients).
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab-paclitaxel + GemcitabineAdministered ion days 1, 8 and 15 of cycles 1 and 3 (28-day cycles). | Drug | Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX |
| modified FOLFIRINOX (mFOLFIRINOX)Administered ion days 1 and 15 of cycles 2 and 4 (28-day cycles). | Drug | Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX |
Primary outcome
One-year event-free survival (1y-EFS)
Time frame: I year
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.
9 secondary outcomes
Proportion of patients who complete the study intervention
Time frame: 1 year
Proportion of patients who require dose modification
Time frame: 1 year
Proportion of patients who undergo surgery
Time frame: 1 year
Radiographic response (unconfirmed) after chemotherapy, per RECIST
Time frame: 1 year
Surgical resection rate (R0, R1 and R2 resection)
Time frame: 1 year
Pathologic response observed in the surgical specimen
Time frame: 1 year
Recurrence-free survival (RFS) in patients who undergo surgery
Time frame: 1 year
EFS (Event Free Survival) and OS (Overall Survival)
Time frame: 1 year
Trend of CA19-9
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nab-paclitaxel + Gemcitabine and modified FOLFIRINOX (mFOLFIRINOX) in people with Pancreas Adenocarcinoma, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Research Nurse (800-639-6918, cancer.research.nurse@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year event-free survival (1y-EFS) (time frame: I year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.