NCT03333356进行中（未招募）不适用
Adjuvant Radiotherapy in Patients With Pathological High-risk Bladder Cancer: A Randomized Multicentre Phase II Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 81
- 试验地点
- 34
- 主要终点
- pelvic recurrence-free survival (PRFS)
研究概览
简要总结
This is a randomized multicentre study in patients with high-risk MIBC to investigate adjuvant radiotherapy after radical cystectomy and pelvic lymph node dissection.
The objective of the study is to provide evidence that adjuvant radiotherapy improves loco-regional control with potential benefits in survival. The study will also evaluate the quality of life of patients and the tolerance of the treatment.
详细描述
INDICATION:
Patients with pathological high-risk muscle invasive bladder cancer treated by radical cystectomy and pelvic lymph nodes dissection
METHODOLOGY:
Multicenter randomised phase II study in high-risk bladder cancer patients treated by radical cystectomy with pelvic lymph nodes dissection assessing :
- Experimental Arm: adjuvant pelvic radiotherapy consisting of 28 x 1.8 Gy fractions (total dose of 50.4 Gy), 5 days per week, 1 fraction /day (duration of RT is 38 days).
- Standard Arm: surveillance. Eligible patients will be randomised, in a 3:1 ratio, to receive either: adjuvant pelvic radiotherapy (Experimental Arm), or surveillance (Standard Arm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •To be eligible, the patients must fulfil all of the following inclusion criteria:
- •Patients with histologically-confirmed muscle-invasive bladder cancer, either with pure urothelial carcinomas, or dominant urothelial carcinomas (>50%) combined with other histological variants including: micropapillary, epidermoid, or adenocarcinomas, are eligible. Patients with small cell variants, pure adenocarcinomas, or pure epidermoid carcinomas are not eligible.
- •Patients with radical cystectomy and pelvic lymph nodes dissection with no microscopic residual disease (R0 and R1).
- •Note that only R1 patients without urinary diversion as orthotropic neo-bladder replacement are eligible for the study, to limit cystectomy bed radiation induced toxicities.
- •Patients with tumours of TNM staging: pN0-2, M0 by imagery, and pT3a, pT3b, pT4a, and pT4b, as well as, pTX-pN1-2, pTX-NX-R1 are eligible.
- •Patients having received neo-adjuvant or adjuvant chemotherapy treatment are eligible. Randomization is allowed only if AE due to chemotherapy are ≤grade 2 at randomization.
- •Patients ≥18 years old.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Absolute neutrophil count (ANC) ≥1500 cells/mm³.
- •Platelets ≥100000 cells/mm³.
- •Haemoglobin ≥8 g/dL (Note: following a blood transfusion or another intervention if required).
- •Adequate hepatic function: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤2.5 x upper limit of normal (ULN); or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.
- •Adequate renal function: clearance >30 mL/min (MDRD).
- •Patients having provided written informed consent prior to any study-related procedures.
- •Patients affiliated to the social security scheme.
- •Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
排除标准
- •Patient must not be enrolled if he/she fulfils any of the following non-inclusion criteria:
- •Patients with R1 resection and with orthotropic neo-bladder reconstruction as urinary diversion are not eligible.
- •Patients with clinical or radiological evidence of metastases or N3 staged bladder cancer are not eligible.
- •Prior invasive solid tumours or haematological malignancies unless disease free for a minimum of 3 years prior to randomisation except:
- •skin basal cell carcinoma,
- •in situ epithelioma of the cervix,
- •or prostate cancer: incidentally discovered during cystoprostatectomy and pelvic lymph node dissection and with a good prognosis (T stage <pT3b and/or Gleason <8 and pN- and/or post-operative prostate-specific antigen (PSA) <0.1 nanogram/mL),
- •Prior pelvic radiotherapy.
- •Patients with active inflammatory bowel disease.
- •Patients who required surgical treatment for bowel obstruction before bladder cancer diagnosis or after cystectomy.
- •Prior chemotherapy for other malignant diseases within the previous 5 years, except for neoadjuvant pre-cystectomy chemotherapy or adjuvant chemotherapy which are permitted.
- •Patients with the following severe acute co-morbidity are not eligible:
- •Unstable angina or congestive heart failure that required hospitalization in the 6 months before randomisation.
- •Transmural myocardial infarction in the 6 months prior to randomisation.
- •Acute bacterial or fungal infection requiring intravenous antibiotics at randomisation.
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of randomisation.
- •Severe hepatic disease: Child-Pugh Class B or C hepatic disease.
- •Known acquired immune deficiency syndrome (AIDS); the study treatment could impact blood count.
- •Patients with any other disease or illness which requires hospitalization or is incompatible with the study treatment are not eligible.
- •Patients unable to comply with study obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the study.
- •Patients enrolled in another therapeutic study within 30 days prior of randomisation.
- •Person deprived of their liberty or under protective custody or guardianship.
结局指标
主要结局
pelvic recurrence-free survival (PRFS)
时间窗: 3 years
The PRFS is defined as the delay between randomization and pelvic recurrence or death, whichever occurs first. The pelvic recurrence will be evaluated according to RECIST V1.1 criteria.
次要结局
- Overall Survival (OS)(5 years)
- Disease-free survival (DFS)(5 years)
- pelvic recurrence-free survival (PRFS)(5 years)
- Metastasis-free survival (MFS)(5 years)
- Disease-specific survival (DSS)(5 years)
- Patients' quality of Life(5 years)
- Patient quality of Life(5 years)
- Tolerance will be evaluated by toxicity: acute (<6 months after RT) and late (≥6 months after RT), assessed using the NCI CTCAE Version N°4.0(5 years)
- Evaluation of acute and late toxicities(5 years)
研究者
研究点 (34)
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