Feasibility Study of Safety, Toxicity, and Compliance of Concomitant Chemoradiotherapy for HIV-Associated Locally-Advanced Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Patients With Adverse Events
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving cisplatin together with radiation therapy may be an effective treatment for cervical cancer.
PURPOSE: This trial studies how well cisplatin and radiation therapy work in treating participants with HIV-associated locally advanced cervical cancer.
详细描述
OBJECTIVES:
Primary
- To determine if it is feasible to administer a regimen of cisplatin/radiotherapy in HIV-infected women with locally advanced cervical cancer (LACC) on antiretroviral therapy (ART).
- To evaluate the safety and tolerability of concomitant chemoradiotherapy with cisplatin in HIV-infected women with LACC who are also receiving concomitant ART.
Secondary
- To determine the 1-year progression-free survival (PFS) of HIV-infected women with LACC Stage IB, II, III, or IVA who receive weekly cisplatin concomitant with radiotherapy and ART. (Exploratory)
- To describe the quality of life (QOL) of enrolled participants via assessments before, immediately after, and at 3 and 9 months after completion of therapy, using QOL metrics that have been validated in similar populations. (Exploratory)
- To describe the effects of treatment on participants' CD4 counts, HIV viral load, and concurrent AIDS-defining conditions. (Exploratory)
- To describe cervical cancer recurrence patterns in HIV-infected participants with LACC defined as loco-regional and/or distant recurrences. (Exploratory)
- To determine 1-year overall survival and causes of death (i.e., cancer-related, HIV-related, or other). (Exploratory)
- To collect serum, cytology, and tissue for future studies specific to cervical and anal disease. (Exploratory)
- To evaluate the effects of weekly cisplatin concomitant with radiotherapy on adherence to ART. (Exploratory)
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
- Female
- 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
Cistplatin and Radiation Therapy
Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).
干预措施: cisplatin (Drug)
Cistplatin and Radiation Therapy
Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).
干预措施: external beam radiation therapy (Radiation)
结局指标
主要结局
Patients With Adverse Events
时间窗: 12 months
Number of patients who experienced one or more adverse events
Treatment Completion Rate
时间窗: 8 weeks
Number of participants who completed therapy
次要结局
未报告次要终点