Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Safety as assessed by number of participants experiencing adverse events
研究概览
简要总结
Primary Objectives:
To determine the disease free survival (DFS) for participants treated with post-operative adjuvant chemotherapy, as compared to neoadjuvant therapy alone.
Secondary Objectives:
To determine the clinical efficacy of the study treatment in terms of median overall survival (OS) and median disease free survival (DFS).
To assess the safety and tolerability of the study treatment regimen as measured by the adverse events rates.
To assess the quality of life in patients receiving the study treatment.
详细描述
The purpose of the research is to compare the usual treatment approach (chemotherapy followed by surgery) to using chemotherapy followed by surgery and then more chemotherapy. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the lifespan of patients compared to the usual approach. There will be two arms of the study. Arm one will receive treatment with gemcitabine and capecitabine every 28 days for 6 cycles. Arm two be will receive standard of care observation. Participants will be asked to undergo imaging (e.g., CT) and laboratory testing to monitor for disease recurrence. The time in the study will be for 30 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically and/or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma
- •Neoadjuvant chemotherapy (for at least three months) ± chemoradiation followed by R0 surgical resection
- •Eastern Cooperative Oncology Group(ECOG) Performance status of PS 0 - 2
- •At least 18 years of age
- •Adequate bone marrow and organ functions as defined by:
- •Absolute neutrophil count ≥ 1000 cells/ μL
- •Hemoglobin ≥ 8 g/ dL
- •Platelets > 75,000 / μL
- •Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault
- •Total bilirubin ≤1.5 ULN
- •AST/ ALT < 2.5 x ULN, unless with liver metastases and then must be <5 x ULN of normal
- •Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately
- •Ability to understand the nature of this study protocol and give written informed consent.
- •Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures
排除标准
- •Receipt of any investigational agents at the time of registration
- •Known, untreated brain metastases
- •Presence of metastatic disease or malignant ascites on diagnostic imaging
- •Grade two or greater peripheral neuropathy
- •Presence of any additional active malignancy within the past 3 years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments
- •Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure (NYHA classification grade III or IV), unstable angina or active arrhythmia
- •Major surgery within the 4 weeks prior to initiation of study treatment
- •A history of allergy or hypersensitivity to any of the study drugs
- •Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study
- •Pregnancy
- •Severe hepatic impairment
- •Participants with known malabsorption
研究组 & 干预措施
Group 1- Gemcitabine and Capecitabine Treatment
Day 1, Day 8, Day 15 • Gemcitabine infused through a vein over 120 minutes
Day 1 - Day 21
• Capecitabine tablets will be taken two times a day; once in the morning and once in the evening. The tablets should not be crushed or split and should be taken with a full glass of water (8 ounces/240 milliliters) within 30 minutes after a meal.
干预措施: Gemcitabine and Capecitabine (Drug)
结局指标
主要结局
Safety as assessed by number of participants experiencing adverse events
时间窗: Five Years
Number of participants experiencing adverse events as defined by Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0 for toxicity
次要结局
未报告次要终点
研究者
Prateek Gulhati, MD, PhD
Prateek Gulhati PI Assistant Professor, Department of Gastrointestinal Medical Oncology
Rutgers, The State University of New Jersey