EUCTR2011-003745-18-DE进行中（未招募）1 期
A PHASE II WINDOW-OF-OPPORTUNITY STUDY OF PREOPERATIVE THERAPY WITH PAZOPANIB (VOTRIENT®) IN HIGH-RISK SOFT TISSUE SARCOMA - NOPASS
niversity of Heidelberg0 个研究点目标入组 35 人开始时间: 2012年4月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
- •2. Age = 18 years or legal age of consent if different from 18 years.
- •3. Histologically confirmed diagnosis of high-risk (G2/3, diameter =5 cm) soft-tissue sarcoma of any location (extremities, girdle, trunk, retroperitoneum). The following soft-tissue sarcoma subtypes are eligible:
- •- Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma)
- •- So-called fibrohistiocytic (pleomorphic MFH”, giant cell MFH”, inflammatory MFH”)
- •- Leiomyosarcoma
- •- Malignant glomus tumors
- •- Skeletal muscle (pleomorphic and alveolar rhabdomyosarcoma)
- •- Vascular (epithelioid haemangioendothelioma, angiosarcoma)
- •- Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, PEComa, intimal sarcoma) excluding chondrosarcoma, Ewing tumors / PNET
- •- Malignant peripheral nerve sheath tumors
- •- Malignant solitary fibrous tumors
- •- Adipocytic sarcoma (all subtypes)
- •- Undifferentiated soft tissue sarcomas not otherwise specified
- •- Other types of sarcoma (not listed as ineligible, see exclusion criteria)
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •5. Measurable disease according to RECIST 1.1
- •6. Resectable and non-metastatic tumor, as assessed by the principal investigator based on staging exams (CT scan of the chest, CT or MRI of the abdomen, MRI of the limb in case of extremity soft-tissue sarcoma).
- •7. Adequate organ system function.
- •8. Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception during the study and until after surgery has been performed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. The following tumor types are ineligible
- •- Embryonal rhabdomyosarcoma
- •- Chondrosarcoma
- •- Osteosarcoma
- •- Ewing tumors / PNET
- •- Gastro-intestinal stromal tumors
- •- Dermofibromatosis sarcoma protuberans
- •- Inflammatory myofibroblastic sarcoma
- •- Malignant mesothelioma
- •2. Prior malignancy. Note: Subjects who have had another malignancy and have been disease-free for 5 years, and subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- •3. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.
- •4. Prior or concurrent systemic chemotherapy or molecularly targeted therapy for STS or other malignancies within five years before study entry.
- •5. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- •- Active peptic ulcer disease
- •- Active inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), 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.
- •6. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- •- Malabsorption syndrome
- •- Major resection of the stomach or small bowel
- •7. Corrected QT interval (QTc) > 480 msecs (see section 6.2).
- •8. Presence of uncontrolled infection.
- •9. History of any one or more of the following cardiovascular conditions within the past 6 months:
- •- Cardiac angioplasty or stenting
- •- Myocardial infarction
- •- Unstable angina
- •- Coronary artery bypass graft surgery
- •- Symptomatic peripheral vascular disease
- •- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- •10. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90mmHg].
- •11. Cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •Note: Subjects with recent DVT who have been therapeutically coagulated for at least 6 weeks are eligible.
- •12. Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement are not considered to be major surgery).
- •13. Evidence of active bleeding or bleeding diathesis.
- •14. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
- •15. Recent hemoptysis (>½ teaspoon of red blood within 8 weeks before first dose of study drug).
- •16. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures.
- •17. Inability or unwillingness to discontinue use of prohibited medications for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of investigational product and for the duration of the study.
- •18. Treatment with any of the following therapies:
- •- radiation therapy, surgery other than incisional biopsy, or tumor embolization, targeting the lesion under study, prior to the first dose of pazopanib OR
- •- chemotherapy,
研究者
相似试验
进行中（未招募）
1 期
A window of opportunity study of enzalutamide (alone or in combination with exemestane) in patients with newly diagnosed breast cancer who are awaiting surgery for their cancer.Primary breast cancerMedDRA version: 18.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-002001-37-ESQueen Mary University London219
进行中（未招募）
1 期
A window of opportunity study of enzalutamide (alone or in combination with exemestane) in patients with newly diagnosed breast cancer who are awaiting surgery for their cancer.EUCTR2014-002001-37-GBQueen Mary University London235
进行中（未招募）
1 期
A window of opportunity study of enzalutamide (alone or in combination with exemestane) in patients with newly diagnosed breast cancer who are awaiting surgery for their cancer.Primary breast cancerMedDRA version: 20.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-002001-37-DEQueen Mary University London235
尚未招募
2 期
HIGH DOSE RADIOTHERAPHY IN SOFT TISSUE SARCOMACTRI/2023/11/060048AIIMS
招募中
2 期
Evaluation of Lymphadenectomy and Chemotherapy TIP (paclitaxel, ifosfamide and cisplatin) on Inguinal Lymph Nodes in Squamous Cell Carcinoma of the Penis2024-512827-36-00Unicancer37