2024-514991-41-01招募中2 期
Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (“URANUS”)
European Uro-Oncology Group Stichting40 个研究点 分布在 3 个国家目标入组 190 人开始时间: 2024年10月17日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 40
- 主要终点
- Proportion of UTUC patients randomized to neo or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy
研究概览
简要总结
To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based chemotherapy treatment. To assess the proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy. To assess the administered versus planned dose of chemotherapy in patients randomized to neo- or adjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •written informed consent • Age ≥ 18 years. • Histological and radiological defined UTUC: Histologically-confirmed diagnosis of predominantly urothelial carcinoma of the upper urinary tract •Patients with UTUC cT2-cT4 cN0-N1 M0 (TNM classification) •Women of childbearing potential must have a negative serum pregnancy test and agree to use effective contraception •Patients without bladder cancer or with concomitant non muscle invasive bladder cancer •Adequate organ system function defined by Hematological results •CT scan of the chest, abdomen and pelvis and bone scan without evidence of distant metastasis
排除标准
- •Histology of pure adenocarcinoma, pure squamous cell carcinoma, sarcomatoid or predominant small cell carcinoma. •History of cardiovascular conditions within the past 6 months. •Incidentally found asymptomatic pulmonary embolism (PE) or recent deep vein thrombosis (DVT) is not an exclusion criteria but requires anticoagulation treatment. •Any major contraindication to a surgical procedure. •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. •Active infection contraindicating chemotherapy (under investigator criteria). •Other active neoplasms •Concomitant muscle invasive bladder cancer. •Patients who have received prior cisplatin based treatment.
结局指标
主要结局
Proportion of UTUC patients randomized to neo or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy
Proportion of UTUC patients randomized to neo or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy
次要结局
- 1- 2 and 3-year Disease Free Survival (DFS), Overall Survival (OS) and Cancer-Specific Survival (CSS)
研究者
Susanne Osanto
Scientific
European Uro-Oncology Group Stichting
研究点 (40)
Loading locations...
相似试验
进行中（未招募）
1 期
Exploratory study of feasibility of chemotherapy treatment before and after surgery in upper tract urothelial carcinomaPatients with upper urinary tract transitional cell carcinoma (UTUC)MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000017553EUCTR2016-004017-27-NLEuropean Uro-Oncology Group (EUOG)210
进行中（未招募）
1 期
Exploratory study of feasibility of chemotherapy treatment before and after surgery in upper tract urothelial carcinomaEUCTR2016-004017-27-ESEuropean Uro-Oncology Group (EUOG)210
招募中
2 期
eo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (*URANUS*)cancer in urinary upper tracturethelial carcinoma1003836410018188NL-OMON48801eids Universitair Medisch Centrum25
进行中（未招募）
1 期
Interest of post-operative chemotherapy in patients with localized uterine leiomyosarcoma suspected to have a high-risk of relapse based on a biologic test performed on the tumor.ocalized, resected, FIGO stage I (2018 classification), uterine leiomyosarcomaCTIS2023-506350-21-00nicancer198
招募中
2 期
Neoadjuvant Chemotherapy followed by Pre-operative Chemoradiation and Consolidation Chemotherapy before Surgery in High Risk Rectal Cancer: Multicentric Phase II Study2024-517183-31-00Centro Di Riferimento Oncologico Di Aviano93