NCT01603004已完成不适用
A Pilot Study to Identify Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are often used to treat pancreatic NETs. Traditional chemotherapy is also known as "cytotoxic therapy" and works by killing cells that are actively dividing. There have been no studies to compare the different types of treatment. Since the patient is eligible for treatment with either sunitinib, everolimus or traditional chemotherapy it can help us identify factors that may help future patients benefit from these therapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histopathologic evidence of well differentiated pancreatic NET
- •Evidence of measurable disease by RECIST 1.
- •Both patients with synchronous disease and those with prior resected primary cancers will be eligible.
- •Patient ≥18 years of age on the day of signing informed consent.
- •Planned initiation of active therapy with everolimus ,sunitinib or traditional cytotoxic chemotherapy.
- •Patients can be included in this study, regardless of prior therapy, but cannot undergo concurrent therapy, such as hepatic artery embolization
- •Available archival tissue with adequate FFPE tissue for analysis verified by a pathologist (in cases of biopsies less than 2 cm and/or less than 70% tumor content 10 slides will be required for adequate DNA preparation. For larger biopsies and any resections, 5 slides are sufficient for DNA extraction).
排除标准
- •Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy are allowed.
- •Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.
结局指标
主要结局
Progression free survival
时间窗: 2 years
standard MRI sequences will be performed, according to guidelines from RECIST 1.1.
次要结局
- Overall survival(5 years)
- best response(5 years)
研究者
研究点 (1)
Loading locations...
相似试验
终止
早期 1 期
Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic CancerLocally Advanced Pancreatic CancerBorderline Pancreatic Inoperable CancerPancreatic CancerNCT03600623University of Alabama at Birmingham25
Unknown
2 期
A Study of Sunitinib Versus Placebo in Combination With Lanreotide in Patients With Progressive Advanced/Metastatic Midgut Carcinoid TumorsCarcinoid TumorsNCT01731925GERCOR - Multidisciplinary Oncology Cooperative Group44
撤回
2 期
A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced MelanomaMelanomaNCT02400385California Pacific Medical Center Research Institute
Unknown
2 期
S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic CancerPancreatic Ductal AdenocarcinomaNCT03316326National Taiwan University Hospital35
已完成
2 期
Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With GemcitabineAcinar Cell Adenocarcinoma of the PancreasDuct Cell Adenocarcinoma of the PancreasRecurrent Pancreatic CancerStage IV Pancreatic CancerNCT00397787National Cancer Institute (NCI)64