NL-OMON39288已完成不适用
Phase I clinical study of a combined modality treatment of sarcomas of the extremities or in head and neck area with radiotherapy (RT) and dose-escalation of Pazopanib - PASART-1
ederlands Kanker Instituut0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- •1. Histologically confirmed newly diagnosed intermediate to high grade soft tissue
- •sarcoma of and localized to the extremities or head and neck for which the treatment is a
- •combination of both surgery and radiotherapy (deep seated, > 5cm according to the RECIST criteria, grade II/III according to the WHO definition).
- •2. Age >= 18 years
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •4. 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
- •5. Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •6. No 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.
- •7. No clinically significant gastrointestinal abnormalities which might interfere with oral dosing diagnosed as:
- •Active peptic ulcer disease
- •Known intraluminal metastatic lesion/s 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
- •Malabsorption syndrome
- •Major resection of the stomach or small bowel
- •8. No uncontrolled hypertension
- •9. No unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
- •10. No poorly controlled hypertension
- •11. No prolongation of corrected QT interval (QTc) >480 msecs.
- •12. No history of any one of more of the following cardiovascular conditions within the past 6 months:
- •a. Cardiac angioplasty or stenting
- •b. Myocardial infarction
- •c. Unstable angina
- •d. Symptomatic peripheral vascular disease
- •e. Coronary artery by-pass graft surgery
- •f. Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
- •g. History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •13. No history of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •Note: Subjects with recent DVT who have been treated with therapeutic anti-
- •coagulant agents (excluding therapeutic warfarin) for at least 6 weeks are eligible.
- •14. No macroscopic hematuria
- •15. No hemoptysis that is clinically relevant within 4 weeks of first dose of study drug.
- •16. No evidence of active bleeding or bleeding diathesis.
- •17. No known endobronchial lesions or involvement of large pulmonary vessels by tumour
- •18. No 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.
- •19. No chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug.
- •20. No biological therapy, hormonal therapy or treatment with an investigational agent within 28 days (for bevacizumab, 60 days) or 5 half-lives, whichever is longer prior to the first dose of study drug.
- •21. No prohibit
排除标准
- •1. Patients with recurrent sarcomas (even without prior radiotherapy) are not eligible. Ineligible sarcoma subtypes as well are: Ewing sarcoma and other PNET family tumors, rhabdomysarcomas (both pediatric and adult), osteosarcomas.
- •2. Patient should not be pregnant or lactating.
研究者
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