Clinical Trial to Define the Effect of Perioperative H. Pylori Eradication With Antibiotic Treatment on Long Term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin Undergoing Cytoreductive Surgery/Hyperthermic Intraperitoneal Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to determine the impact of antibiotic therapy on the disease progression and overall survival of patients with Pseudomyxoma Peritonei (PMP).
详细描述
Single center, open label, historical controlled, phase II study that proposes two courses of standard H. Pylori eradication antibiotic therapy can suppress carcinogenesis and improve the long-term outcomes of patients with PMP. The first course of antibiotics (PrevPac) will be administered before cytoreductive surgery and HIPEC and the second course afterwards. The historical control group will consist of all PMP patients from Mercy Medical Center's Tumor Registry who did not receive perioperative antibiotic treatment. Long-term statistical outcomes will be calculated using the Kaplan-Meier method and Cox proportional hazard ratio to compare pertinent variable. 80 subjects to be enrolled over 2 years, with a 5 year follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must have measurable pseudomyxoma peritonei from appendiceal origin, confirmed by histology, cytology, or radiographical evidence -
- •Age ≥ 21 years
- •Eastern Cooperative Oncology Group (ECOG) performance status score≤2/Karnofsky performance status of (KPS) ≥ 70% (see Appendix B)
- •Patients must have normal organ and marrow function as defined below:
- •Absolute neutrophil count (ANC) ≥1,000/mm3 Platelets ≥100,000/mm3 Hemoglobin ≥ 8.5 g/dL
- •Renal function:
- •Creatinine ≤1.5 times the upper limit of normal (ULN) or calculated creatinine clearance ≥60ml/min
- •Hepatic function:
- •Bilirubin ≤1.5 times ULN Alanine aminotransferase (ALT) ≤3 times ULN Aspartate aminotransferase (AST) ≤3 times ULN
- •Ability of subject or Legally Authorized Representative (LAR) to understand and willingness to sign a written informed consent, approved by Mercy Medical Center Institutional Review Board (IRB)
- •A negative pregnancy test for women of childbearing age with all reproductive organs intact
排除标准
- •Patients receiving any other investigational agents
- •Presence of other invasive malignancies or evidence of another cancer present within the last 3 years, excluding skin cancer
- •history of, or known allergic reaction/hypersensitivity to PREVPAC or any component of similar chemical or biologic composition to PREVPAC
- •Patients < 21 of age
- •Pregnancy or lactation at the time of proposed assignment. Pregnant women are excluded from this study because PREVPAC is based on the pregnancy category for clarithromycin which is Category C agent with the potential for teratogenic or abortifacient effects. These potential risks may also apply to CRS/HIPEC.
- •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g., unable to swallow pills)
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or giving informed consent
- •Known active acute hepatitis and confirmed diagnosis of Human Immunodeficiency Virus (HIV) infection. HIV-positive patients on combination antiretroviral therapy are ineligible. These patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- •Active systemic infection that requires use of parenteral antibiotics
- •Renal insufficiency with serum creatinine level ≥1.5 times the upper limit of normal or calculated -
- •Patients with concurrent severe medical problems unrelated to malignancy that will preclude compliance with the study or places at an unacceptable risk for participation in the study determinate by study investigators
- •Patients to be maintained on any medication having severe interactions with PREVPAC
研究组 & 干预措施
PrevPac
Study intervention: PrevPac (Prevacid, Amoxicillin, Clarithromycin)twice daily x 14 days for 2 courses (preoperative and post-operative).
All eligible patients with a PMP diagnosis, undergoing CRS/HIPEC treatment, who consent to study participation will have a urea breath test prior to the first course of PrevPac.
After surgery, when tolerated, each patient will take a second course of PrevPac. Patients will be seen for follow-up as clinically indicated until year 5.
干预措施: PrevPac (Prevacid, Amoxicillin, Clarithromycin) (Drug)
结局指标
主要结局
Overall survival
时间窗: 5 year
Kaplan-Meier survival estimates
次要结局
- Progression-free survival measured by no evidence of disease progression, i.e. tumor markers within normal limits, no radiographical evidence of disease(5 year)