Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Gastrointestinal (GI) late effects, assessed using Radiation Therapy Oncology Group (RTOG) Late Effects in Normal Tissues (LENT)/Subjective, Objective, Management and Analytic (SOMA) scales
研究概览
简要总结
This phase II trial studies how well modern, conformal radiation therapy after surgery works in treating patients with high-risk bladder cancer. 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.
详细描述
PRIMARY OBJECTIVE:
I. Determine the feasibility of adjuvant radiation in the management of high-risk disease.
SECONDARY OBJECTIVES:
I. Prospectively evaluate patterns of failure in high-risk bladder cancer patients after cystectomy and aggressive adjuvant therapy.
II. Define surgical and histopathologic parameters predictive of local and distant outcomes (e.g. grade, lymphovascular space invasion [LVSI], extent of resection/lymph node dissection [LND]).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic diagnosis of urothelial or squamous cell carcinoma of the bladder
- •Patients must have undergone cystectomy (total cystectomy, radical cystectomy +/- pelvic lymph node dissection) with no evidence of macroscopic residual disease
- •Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
- •Patients treated with simple cystectomy with macroscopically negative margins are eligible for this study
- •Clinical T-stage (prior to systemic therapy, if applicable) ≥ T3a and/or positive lymph nodes by transurethral resection of bladder tumor (TURBT)/magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET)-CT or pathologic T-stage ≥ T3a and/or positive lymph nodes
排除标准
- •Patients with metastatic disease outside of the pelvis
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- •Prior radiation therapy to the pelvis
- •Patients with active inflammatory bowel disease
- •Severe acute co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immunocompromised patients
结局指标
主要结局
Gastrointestinal (GI) late effects, assessed using Radiation Therapy Oncology Group (RTOG) Late Effects in Normal Tissues (LENT)/Subjective, Objective, Management and Analytic (SOMA) scales
时间窗: 3 months to 10 yrs
For purposes of this study, "bowel adverse events" are defined as the following: diarrhea, enteritis, fistula, ileus, incontinence, obstruction, perforation, proctitis, and stricture/stenosis (including anastomotic) as graded buy Common Terminology for Adverse Events (CTCAE) version 4.0.
次要结局
- Loco-regional failure, considered any failure in the treatment field of the pelvis(Up to 5 years)
- Rate of distant metastases(Up to 5 years)
- Overall survival rate(Up to 5 years)
- Acute adverse events greater than grade 2, graded by CTCAE version 4.0(Up to 90 days)
- Rate of disease-free survival(Up to 5 years)
- Quality of life, assessed using FACT-BL(Up to 5 years)
研究者
Joseph W Shelton MD
Principal Investigator
Emory University