Combined Modality Treatment of Sarcomas of the Extremities (PASART-1)
Phase I Clinical Study of a Combined Modality Treatment of Sarcomas of the Extremities With Radiotherapy (RT) and Dose-escalation of Pazopanib
研究概览
详细说明
Study design A dose escalation trial of Pazopanib, starting at 400mg daily, orally in combination with the standard 25 x 2Gy preoperative radiotherapy in newly diagnosed extremity sarcoma patients. Dose of pazopanib will be escalated via 600mg to maximally 800mg. Overall treatment time of pazopanib is 40 days.
Treatment plan: Pazopanib Dose level Dose of pazopanib orally, once daily, # patients
- (starting) 400 mg 3
- 600 mg 3
- (maximum) 800 mg 3
Treatment plan: radiotherapy RT is given during 5 weeks with a once daily fraction of 2 Gray (50 Gray in 25 daily fractions)
RT planning: The dose planning should be performed by CT based Intensity Modulated RT (IMRT) or 3 Dimensional Conformal RT (3D-RT) according to the local planning protocol of the participating institute.
Dose specification: According to the ICRU 50/62.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Noord Holland
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Amsterdam、Noord Holland、荷兰、1066CX
- The Netherlands Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma of and localized to the extremities or head and neck area for which the treatment is a combination of both surgery and radiotherapy (deep seated, > 5cm according to the RECIST 1.1 criteria, grade II/III according to the WHO definition).
- Age > 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
6 Able to swallow and retain oral medication. 7. A life expectancy of at least 12 weeks. 8. Adequate organ function.
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Exclusion Criteria:
- Prior malignancies; except subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- Patients with recurrent sarcomas (even without prior radiotherapy).
- Ewing sarcoma and other PNET family tumours, rhabdomyosarcomas (both pediatric and adult), osteosarcomas.
Clinically significant gastrointestinal abnormalities which might interfere with oral dosing diagnosed as:
- Active peptic ulcer disease.
- Known intraluminal metastatic lesions with suspected bleeding.
- Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation.
- History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- Major resection of the stomach or small bowel.
- Uncontrolled hypertension.
- Unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
- Prolongation of corrected QT interval (QTc) >480 msecs.
History of any one of more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting.
- Myocardial infarction.
- Unstable angina.
- Symptomatic peripheral vascular disease.
- Coronary artery by-pass graft surgery.
- Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA).
- History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Macroscopic hematuria
- Haemoptysis that is clinically relevant within 4 weeks of first dose of study drug.
- Evidence of active bleeding or bleeding diathesis.
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug.
- Biological therapy or treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug.
- Prohibited medications listed in the protocol for 14 days or five half-lives of a drug (whichever is longer) prior to Visit 1 and for the duration of the study should not be taken.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
- Pregnancy or lactating.
Hypothyroidism.
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学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:cohort
Dose level Dose of pazopanib orally, once daily, # patients -1 200 mg --
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A dose escalation trial of Pazopanib, starting at 400mg daily, orally in combination with the standard 25 x 2Gy preoperative radiotherapy in newly diagnosed extremity sarcoma patients.
Dose of pazopanib will be escalated via 600mg to maximally 800mg.
Overall treatment time of pazopanib is 40 days.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Dose limiting toxicity
大体时间:14 weeks
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To study the safety and feasibility of adding 6 weeks of orally administered Pazopanib to 25 x 2Gy in 5 weeks preoperative radiotherapy in extremity or head and neck area soft tissue sarcoma patients (to identify the Dose Limiting Toxicity (DLT) and the Recommend Phase II Dose (RPTD) if pazopanib is added to 50 Gy pre-operatively)
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14 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
the exploration/feasibility of dynamic imaging
大体时间:14 weeks
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The secondary objective is to explore the feasibility to perform perfusion weighted MRI imaging regarding tumor respons to RT and neoangio genesis inhibitor by pazopanib.
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14 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- M09RTP
- 2009-014901-15 (EudraCT编号)
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