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
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 1
- 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
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
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)