A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint is Progression Free Survival (PFS). PFS is defined as the time (in months) from the randomized treatment assignment to documentation of disease progression (RECIST 1.1) or death from any cause, whichever comes first.
研究概览
简要总结
To examine if letrozole monotherapy/maintenance (L/L) is noninferior to IV paclitaxel/carboplatin and maintenance letrozole (CT/L) with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction
研究设计
- 分配方式
- Randomized
- 主要目的
- Two Arm Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
- •Patients must have adequate organ and marrow function as defined below: - Bone marrow function within 14 days prior to registration defined as follows: o Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl o Platelets greater than or equal to 100,000 cells/mcl - Adequate renal function within 14 days prior to registration defined as follows: o Creatinine less than or equal to 1.5 x ULN -Adequate hepatic function within 14 days prior to registration defined as follows: o Bilirubin less than or equal to 1.5 x ULN o ALT and AST less than or equal to 3 x ULN
- •The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer (submission of pathology report(s) required). Ovarian cancer = ovarian, fallopian tube and primary peritoneal cancers. NOTE: Patients with a prior history of serous borderline tumors but a new diagnosis of Stage II-IV low-grade serous ovarian cancer are eligible. • p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53). If aberrant p53 expression is found on p53 IHC, the patient is NOT eligible (e.g., aberrant p53 expression is consistent with mutant TP53 and supports a diagnosis of high grade serous ovarian cancer).
- •Appropriate stage for study entry based on the following diagnostic workup: o History/physical examination within 14 days prior to registration; o Contrast-enhanced imaging of the chest, abdomen and pelvis within 28 days prior to registration.
- •Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (<=1cm diameter residual disease/nodule) or suboptimal residual disease (>1 cm diameter residual disease/nodule) status allowed.
- •Patients must have undergone a bilateral salpingo-oophorectomy
- •Patients must have an ECOG Performance Status of 0, 1 or 2 within 14 days prior to registration (protocol Appendix I).
- •Patients must be within ≤8 weeks of primary cytoreductive surgery at time of randomization.
- •Patients must be able to take per oral (P.O.) medications.
排除标准
- •Patients with any of the following conditions are NOT eligible for this study.
- •Patients may not have received neoadjuvant or adjuvant chemotherapy or radiotherapy for the treatment of this disease.
- •Patients with known hypersensitivity to letrozole or hypersensitivity/intolerance to carboplatin/paclitaxel therapy.
- •Patients with severe cardiac disease: • Myocardial infarction or unstable angina within 6 months prior to registration. • New York Heart Association (NYHA) Class II or greater congestive heart failure (protocol Appendix II).
- •Patients with known central nervous system metastases
- •Patients with active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection.
- •Patients with ≥grade 2 baseline neuropathy
- •Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- •Patients may not have received previous hormonal therapy for the treatment of this disease.
结局指标
主要结局
The primary efficacy endpoint is Progression Free Survival (PFS). PFS is defined as the time (in months) from the randomized treatment assignment to documentation of disease progression (RECIST 1.1) or death from any cause, whichever comes first.
The primary efficacy endpoint is Progression Free Survival (PFS). PFS is defined as the time (in months) from the randomized treatment assignment to documentation of disease progression (RECIST 1.1) or death from any cause, whichever comes first.
The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed. The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status.
The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed. The PFS comparison will be assessed at the second interim and final analyses using a logrank test stratified by country and residual disease status.
Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events.
Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events.
次要结局
- Toxicity
- Objective Tumour Response
- Overall Survival
- Adherence to Letrozole Maintenance Therapy
- The study includes two interim analyses. At 20% information time, a futility analysis will be conducted. At 40% information time, both efficacy and futility will be assessed.
- Full analysis will be performed after the date on which the last participant was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events.
研究者
Head of Operations
Scientific
Cancer Trials Ireland