Comparison of Treatment Adherence and Toxicities of HIV Positive Patients Versus HIV Negative Cervical Cancer Patients in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Completion Rates of Cancer Treatment
研究概览
简要总结
The investigators propose to prospectively study the difference in treatment (CTRT) completion and toxicities between HIV positive and HIV negative women in India with locally advanced cervical cancer receiving CTRT.
详细描述
This study will compare chemoradiation completion rates for cervical cancer in two groups, women with HIV and women without HIV. The investigators will also be analyzing tumor tissue for tumor infiltrating lymphocytes which are thought to be involved in disease progression.
研究设计
- 研究类型
- 观察性
- 观察模型
- 病例对照
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- patients with newly biopsy proven squamous carcinoma or adenocarcinoma of the uterine cervix, FIGO stage IB2-IIIB in whom curative CTRT is planned
- Karnofsky performance status ≥ 70
- Patients with lower paraortic lymph nodes (below the level of L2 vertebra)
- patients diagnosed with cervical cancer whom also HIV positive or HIV negative
排除标准
- patients with active tuberculosis
研究组 & 干预措施
HIV Positive
Cervical Cancer Patients with HIV positive
干预措施: Radiation Therapy (Radiation)
HIV Negative
Cervical Cancer Patients with HIV negative
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Completion Rates of Cancer Treatment
时间窗: 2 years
To evaluate and compare the completion rates of cancer treatment in HIV positive cervical cancer patients and HIV negative cervical cancer patients. Treatment adherence is defined as receiving at least 5 cycles of weekly cisplatin chemotherapy and completion of all prescribed radiation (including brachytherapy) and chemotherapy within 8 weeks of treatment initiation.
Impact of HIV Infection on acute toxicities
时间窗: 2 years
To compare the incidence of acute grade ≥3 gastrointestinal, genitourinary and hematological toxicities using CTCAE v4 in patients receiving concurrent cisplatin-based chemo-radiation and brachytherapy for cervical cancer in HIV positive and HIV negative patients. Acute toxicities include any toxicity occurring within 90 days of treatment completion.
次要结局
- Tumor infiltrating lymphocytes (TILs)(2 Years)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07167069
- 其他研究编号
- UPCC 20824, 834664, DAA3-19-65331-1
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (29天前)
- 研究完成日期
- (29天前)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否