The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG
研究概览
简要总结
To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive (NMIBC) patients treated with BCG or gemcitabine.
详细描述
Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC, however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of BCG has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. According to current evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in NMIBC patients, including those at high-risk of disease recurrence, even if its role on the management of NMIBC has not been well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with BCG or gemcitabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, >3 cm in diameter)
- •WHO performance status ≤2
- •age ≤85years
- •BCG naive
- •patients not treated with intravesical chemotherapy in the last 3 months.
排除标准
- •presence of T1G3 or CIS
- •preoperative urinary cytology positive for high-grade atypia
- •inadequate bone marrow reserve (white blood cells <3 x 109/l, platelets <100 x 109/l)
- •history of genito-urinary tuberculosis
- •presence of uncontrolled urinary infections.
研究组 & 干预措施
Gemcitabine-arm
7-15 days after TUR patients received six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline. Maintenance consisted in monthly instillations up to 1 year
干预措施: Gemcitabine 2 g (Drug)
BCG-arm
7-15 days after TUR patients received an induction cycle of six weekly instillations of Connaught strain Bacillus Calmette-Guerin (BCG Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline. Maintenance consisted of 3 weekly instillations at 3, 6 and 12 months
干预措施: BCG Vaccine (Drug)
结局指标
主要结局
quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG
时间窗: 1 year
次要结局
- comparison of the short term efficacy of the two treatments in terms of recurrence(1 year)
- comparison of the short term efficacy of the two treatments in terms of progression(1 year)
研究者
Marco Oderda
MD
Azienda Ospedaliera San Giovanni Battista