24BRO681 : Neoadjuvant Therapy With Alternating Gemcitabine Plus Nab-Paclitaxel and mFOLFIRINOX for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- One-year event-free survival (1y-EFS)
研究概览
简要总结
The purpose of this research is to study the effects and safety of alternating neoadjuvant chemotherapy on borderline resectable pancreatic cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Treatment with Gemcitabine plus Nab-Paclitaxel and 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.
干预措施: modified FOLFIRINOX (mFOLFIRINOX) (Drug)
Treatment with Gemcitabine plus Nab-Paclitaxel and 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.
干预措施: Nab-paclitaxel + Gemcitabine (Drug)
结局指标
主要结局
One-year event-free survival (1y-EFS)
时间窗: 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.
One-year event-free survival (1y-EFS)
时间窗: 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.
次要结局
- Surgical resection rate (R0, R1 and R2 resection)(1 year)
- Pathologic response observed in the surgical specimen(1 year)
- EFS (Event Free Survival) and OS (Overall Survival)(1 year)
- Trend of CA19-9(1 year)
- Proportion of patients who complete the study intervention(1 year)
- Recurrence-free survival (RFS) in patients who undergo surgery(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)
- 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)
- Pathologic response observed in the surgical specimen(1 year)
- Recurrence-free survival (RFS) in patients who undergo surgery(1 year)
- Trend of CA19-9(1 year)
研究者
Gabriel A. Brooks
Principal Investigator
Dartmouth-Hitchcock Medical Center