ACTRN12616000331437终止未知
A Prospective Observational Trial Evaluating Outcomes of FoundationOne (Registered Trademark)-Directed Matched Targeted Therapy in Patients with Cancer of Unknown Primary (CUP).
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Histological or cytological confirmed diagnosis of metastatic or advanced unresectable CUP including adenocarcinoma, poorly differentiated adenocarcinoma, poorly differentiated carcinoma, or squamous carcinoma.
- •2. To be categorized as CUP, the following clinical evaluations must have been performed
- •without identification of an anatomic primary site: medical history, physical examination,
- •chemistry profile, blood counts, serum PSA (men), CT scans of chest/abdomen/pelvis,
- •specific evaluation of symptomatic areas.
- •3. Sufficient Formalin Fixed Paraffin Embedded tissue from cancer of unknown primary available for FoundationOne (Registered Trademark) testing.
- •4. First and second line patients must have an ECOG Status score of 0 to 2. Third line patients enrolling in this study must have an ECOG Status score of 0 to 1.
- •5. Measurable or evaluable disease per RECIST version 1.1
- •6. Patients are considered potential candidates for treatment with targeted therapy.
- •7. Willingness and ability to comply with study and follow-up procedures.
- •8. Ability to understand the nature of this study and give written informed consent.
- •9. Presence of other active cancers is not allowed, unless indolent and not requiring therapy. Patients with early stage cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of nonmelanoma skin cancer.
排除标准
- •1. Received three or more lines of prior therapy for CUP.
- •2. Previously received matched targeted therapy for the same Class 1 alteration or the same drug.
- •3. Treatable CUP syndrome, including the following: a. extragonadal germ cell syndrome,
- •b. neuroendocrine carcinoma, c. adenocarcinoma isolated to axillary lymph nodes (women), d. peritoneal carcinomatosis (women), e. squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes, and f. single resectable metastasis.
- •4. Previously untreated brain metastases. Patients who have received radiation or surgery or brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
- •5. Enzyme inducing anticonvulsants
- •6. Pregnant or lactating.
- •7. Psychological, familial, sociologic, or geographic conditions that do not permit compliance with the protocol.
研究者
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