Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05825066
Phase
PHASE2
Status
Recruiting
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Conditions

  • Borderline Resectable Pancreatic Adenocarcinoma
  • Locally Advanced Pancreatic Adenocarcinoma
  • Pancreas Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Nab paclitaxel — DRUG
    The intervention will be administered on an outpatient basis. The patients on this study will begin treatment with GA for one month and then transition to mFFX for one month. The patient will come off of the sequence study intervention if the imaging after the 2nd month shows unequivocal progression. After four months of sequential neoadjuvant therapy the patient will come off study and can proceed to surgery, radiation, or extended course of chemotherapy as determined by the multidisciplinary tumor board consensus or the treating physician.
  • Gemcitabine — DRUG
    The intervention will be administered on an outpatient basis. The patients on this study will begin treatment with GA for one month and then transition to mFFX for one month. The patient will come off of the sequence study intervention if the imaging after the 2nd month shows unequivocal progression. After four months of sequential neoadjuvant therapy the patient will come off study and can proceed to surgery, radiation, or extended course of chemotherapy as determined by the multidisciplinary tumor board consensus or the treating physician.
  • Radiological Assessments — OTHER
    CT imaging of chest abdomen and pelvis will be performed every 8 weeks. MRI may be used.
  • mFOLFIRINOX — DRUG
    The intervention will be administered on an outpatient basis. The patients on this study will begin treatment with GA for one month and then transition to mFFX for one month. The patient will come off of the sequence study intervention if the imaging after the 2nd month shows unequivocal progression. After four months of sequential neoadjuvant therapy the patient will come off study and can proceed to surgery, radiation, or extended course of chemotherapy as determined by the multidisciplinary tumor board consensus or the treating physician.

Study Details

The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.

Key Dates

Start date
Aug 1, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)
    * Gemcitabine (1000 mg/m2 weekly, on day 1,8 and 15 OR 1000 mg/m2 weekly, on day 1 and 15 over 30 minutes after nab-paclitaxel infusion. * nab-Paclitaxel (125 mg/m2 weekly, on days 1,8, and 15 OR on days 1 and 15 as a 30-40 minute infusion administered first) for one month and then transition to mFOLFIRNIOX for one month 1 Cycle = 4 weeks: Day 1,8,15 in a 28 day cycle; 3 consecutive weeks (weeks 1, 2, and 3) of chemotherapy with 1 week off, OR 1 Cycle = 4 weeks: Day 1, 15 in a 28 day cycle; Every other week (weeks 1 and 3) of chemotherapy with 2nd and 4th week off * mFOLFIRINOX: Oxaliplatin, 85 mg/m² IV once every two weeks over 2 hours on Day 1 Irinotecan, 150 mg/m² IV once every two weeks over 90 minutes on Day 1 5-FU, 2,400 mg/m² IV once every two weeks over 46-48 hours administered via infusion Leucovorin, 400 mg/m2 IV every two weeks over 90 minutes on Day 1 1. Cycle = 4 weeks, administration on Day 1 and Day 15 of each mFOLIRINOX cycle

Primary Outcome Measure

R0 Resection Rate - Borderline Resectable Prostate Cancer Participants [ Time Frame: Approximately every 8 weeks, up to 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Baptist Comprehensive Cancer CenterWinston-SalemNorth Carolina27157
Study Coordinator
[email protected]
336-713-6912
Ravi K Paluri, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Wake Forest Baptist Comprehensive Cancer Center· Winston-Salem, NC

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