A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 13
- 主要终点
- Percentage of Participants Free From Radical Cystectomy at 3 Years
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, mitomycin C, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well radiation therapy given together with chemotherapy works in treating patients with stage I bladder cancer.
详细描述
After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and annually thereafter until termination of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
3DCRT + CT
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
干预措施: cisplatin (Drug)
3DCRT + CT
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
干预措施: 5-fluorouracil (Drug)
3DCRT + CT
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
干预措施: Mitomycin (Drug)
3DCRT + CT
Concurrent three-dimensional conformal radiation therapy (3DCRT) and radiosensitizing chemotherapy (CT) consisting of either cisplatin alone or the combination of mitomycin and 5-fluorouracil. Protocol treatment must begin with 15 weeks after a transurethral resection of the tumor (TURBT).
干预措施: Three-Dimensional Conformal Radiation Therapy (Radiation)
结局指标
主要结局
Percentage of Participants Free From Radical Cystectomy at 3 Years
时间窗: Three years from registration
The number of participants who did not undergo a radical cystectomy within three years divided by the number of analyzed participants, presented with the 97.5% lower bound.
次要结局
- Percentage of Participants With Progression to Tumor Stage T2 or Greater at 5 Years(From registration to five years)
- Percentage of Participants Free From Radical Cystectomy at 5 Years(Five years from registration)
- Percent of Participants With Distant Disease Progression at 5 Years(From registration to five years)
- Percent of Participants With Distant Disease Progression at 3 Years(From registration to three years)
- Percentage of Participants Alive at 5 Years(From registration to five years)
- Distribution of Participants by Highest Grade Adverse Event(Adverse events are evaluated 8-10 weeks after end of study treatment (approximately 7 weeks), then every 3 months for one year, every 4 months for one year, every 6 months for 3 years, then annually. Maximum follow-up at time of reporting was 8.6 years.)
- American Urological Association Total Symptom Score at Baseline and at 3 Years(Baseline and 3 years)
- Percentage of Participants With Progression to Tumor Stage T2 or Greater at 3 Years(From registration to three years)
- Percentage of Participants Alive at 3 Years(From registration to three years)
- Percentage of Participants Who Have Died From Bladder Cancer at 5 Years (Disease-specific Survival)(From registration to five years)
- Percentage of Participants With Local Recurrence at 3 Years(From registration to three years)