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New treatment option for Pancreas Adenocarcinoma
Official title 24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC
ClinicalTrials.gov ID: NCT07043270
What this study is testing
What is Nab-paclitaxel + Gemcitabine?
Nab-paclitaxel + Gemcitabine is an investigational medicine, being studied as a potential treatment for pancreas adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Diagnosis of BR-PDAC. The resectability should be officially determined with surgical oncologists at the Dartmouth Cancer Center (DCC) GI...
- 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.
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.