Chemotherapy-based Split Stereotactic Body Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: Study Protocol of a Prospective, Single-arm Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Kaplan-Meier Estimate of Progression-Free Survival (PFS)
研究概览
简要总结
Exploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with SBRT in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (IC).
详细描述
The question of how to administer adequate chemotherapy to synchronize SBRT treatment strategy to maximize the benefits of neoadjuvant therapy for improved prognosis of patients with borderline resectable (BRPC) and locally advanced (LAPC) pancreatic cancer is a challenging and debatable issue. No studies have yet evaluated the efficacy of split-course SBRT as the neoadjuvant chemoradiotherapy regimen. The investigators aimed to study whether neoadjuvant chemotherapy plus split-course SBRT results in better outcomes in BRPC and LAPC patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old and ≤ 70 years old.
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas.
- •Borderline resectable or locally advanced pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines
- •No prior chemotherapy or radiotherapy
- •ECOG performance status of 0 or
- •Without distant metastasis
- •The maximum diameter of the tumor must not exceed 5 cm
- •Acceptable hematology parameters: a. Absolute neutrophil count (ANC) ≥1500 cell/mm3 b. Platelet count ≥100,000/mm3 c. Hemoglobin (Hgb)≥9 g/dL
- •Acceptable blood chemistry levels: a. AST/SGOT and ALT/SGPT≤2.5× upper limit of normal range (ULN) b. Total bilirubin≤1.5 ULN c. Alkaline phosphatase≤2.5× ULN d. Serum albumin>3 g/dL e. Serum creatinine≤1.5 ULN
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
排除标准
- •Age < 18 years old and > 70 years old. Prior anticancer therapy for pancreatic carcinoma.
- •Presence of or history of metastatic pancreatic adenocarcinoma.
- •Patients who had surgeries, chemotherapy, or other treatments before inclusion.
- •Any other malignancy within 5 years prior to enrollment
- •History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients.
- •Peripheral sensory neuropathy Grade > 1
- •Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders.
- •Pregnant or breast feeding.
- •Patients enrolled in other clinical trials or incompliant with regular follow-up
- •Unwillingness or inability to comply with study procedures.
研究组 & 干预措施
SBRT with concurrent chemotherapy
SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy
干预措施: nab-Paclitaxel+Gemcitabine (Drug)
SBRT with concurrent chemotherapy
SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy
干预措施: split-course SBRT (Radiation)
结局指标
主要结局
Kaplan-Meier Estimate of Progression-Free Survival (PFS)
时间窗: From enrollment to 2 years after the end of treatment
Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.
次要结局
- Kaplan-Meier Estimates for Time to Treatment Failure (TTF)(From enrollment to 2 years after the end of treatment)
- Disease Control Rate (DCR)(From enrollment to 2 years after the end of treatment)
- Overall Response Rate (ORR)(From enrollment to 2 years after the end of treatment)
- Kaplan-Meier Estimates for Overall Survival (OS)(From enrollment to 2 years after the end of treatment)
- Participants With Treatment Emergent Adverse Events (TEAEs)(From enrollment to 2 years after the end of treatment)
研究者
Benhua Xu
Director
Fujian Medical University Union Hospital