Health TrialsbyHealthPanel

24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC

ConditionPancreas Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Nab-paclitaxel + Gemcitabine

    Drug

    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).

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOXExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
I year

Secondary outcomes

1

Proportion of patients who complete the study intervention

Time frame
1 year
2

Proportion of patients who require dose modification

Time frame
1 year
3

Proportion of patients who undergo surgery

Time frame
1 year
4

Radiographic response (unconfirmed) after chemotherapy, per RECIST

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dartmouth-Hitchcock Medical Center

Lead sponsor

Source ClinicalTrials.gov
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