NL-OMON56809尚未招募不适用
Stereotactic body radiation therapy after chemotherapy for unresectable perihilar cholangiocarcinoma: a multicenter phase II trial (The STRONG 2 trial) - The STRONG II trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The initial translational part of the study will be performed in patients with
- •unresectable pCCA eligible for standard chemotherapy with cisplatin and
- •gemcitabine. After chemotherapy, the patients will proceed to SBRT if they are
- •still eligible based on the following inclusion and exclusion criteria (see
- •below). It may happen that patients do not give consent for the translational
- •part of the study, but they may wish to participate in the SBRT part of the
- •trial and vice versa.
- •Inclusion criteria translational part of the study:
- •In order to be eligible to participate in the translational part of the study,
- •a subject must be discussed in a liver tumor board, should be eligible for
- •standard chemotherapy (and immunotherapy, if applicable), and should meet all
- •of the following criteria pre-chemotherapy:
- •- pCCA according to the criteria of the Mayo Clinic, Rochester (22):
- •o Positive or strongly suspicious intraluminal brush cytology or biopsy or,
- •o A radiographic malignant appearing stricture plus either:
- •* CA 19-9>100 U/ml in the absence of acute bacterial cholangitis, or
- •* polysomy on fluorescence in situ hybridization (FISH), or
- •* a well-defined mass on cross sectional imaging
- •- One tumor mass
- •- Unresectable tumor
- •- T1-T4 (AJCC staging 8th edition), N0-N1-M0 (AJCC staging 8th edition),
- •radiologically or pathologically suspect
- •- In case of (underlying) liver cirrhosis: Child-Pugh A
- •- Age >= 18 years
- •- ECOG performance status 0-1
- •- Written informed consent for the translational part of the study
- •Inclusion criteria SBRT part of the study:
- •Additionally, to the criteria mentioned above, patients should meet the
- •following criteria to be eligible for the treatment with SBRT:
- •- Measurable disease to be selected as a target on a computed tomography (CT)
- •or magnetic resonance imaging (MRI) scan, according to RECIST 1.1 criteria
- •- Tumor visibility on CT
- •- Finished chemotherapy treatment with gemcitabine and cisplatin, preferably 8
- •cycles. If less cycles are given, patients are still eligible for this study
- •- Bilirubin <=1.5 times normal value, aspartate aminotransferase (AST)/alanine
- •transami-nase (ALT) <=5 times ULN
- •- Platelets >= 50x10E9/ l, Leukocytes > 1.5x10E9/l, Hemoglobin (Hb) > 6 mmol/l
- •- Willing and able to comply to the follow-up schedule
- •- Able to start SBRT within 12 weeks after completion of chemotherapy and
- •immuno-therapy (if applicable)
- •- Written informed consent for the SBRT part of the study
排除标准
- •Exclusion criteria translational part of the study
- •- Prior surgery or transplantation of the liver
- •- Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall
- •- Prior radiotherapy to the liver
- •- Current pregnancy
- •Exclusion criteria SBRT part of the study:
- •Progression (local or distant) during or after chemotherapy
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