Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC): a Phase II Prospective Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment
- •T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- •Age > 18 years
- •Willingness to undergo 18F-FDG-PET-CT
- •Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively
- •Willingness and ability to provide a signed informed consent according to ICH/GCP and national/local regulations
排除标准
- •Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT/ MRI)
- •Refusal of or having contraindications to 18F-FDG-PET-CT
- •Refusal of MDT or immunotherapy
- •Prior radiotherapy unabling MDT
- •Contraindications to radiotherapy (including active inflammatory bowel disease)
- •Contraindications to immunotherapy
- •Other primary tumor diagnosed < 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.
研究组 & 干预措施
Non-metastatic MIBC
No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) and 18F-FDG-PET-CT's
干预措施: Standard of care (Procedure)
Oligo-metastatic MIBC on 18F-FDG-PET-CT
No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of ≤ 3 metastasis on 1 or both 18F FDG PET-CT 's
干预措施: Metastasis directed therapy (MDT) (Radiation)
Poly-metastatic MIBC on 18F-FDG-PET-CT
No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT/MRI) but presence of > 3 metastasis on 1 or both 18F FDG PET-CT 's
干预措施: Immunotherapy (Drug)
结局指标
主要结局
Overall survival
时间窗: 2 years
Defined as the time from diagnosis of MIBC to death from any cause
次要结局
- Patient reported quality of life as per EORTC-QLQ C30(5 years)
- Distant metastasis-free survival(5 years)
- Disease specific survival(5 years)
- Validation of predictive biomarkers(5 years)
- Patient reported quality of life as per EORTC-QLQ BLM30(5 years)
- The number of patients with late toxicity(5 years)
- Progression-free survival(5 years)
- The number of patients with acute toxicity(3 months)
- Sensitivity/specificity of 18F-FDG-PET-CT for the detection of extra-pelvic metastases(3 months)