Prospective Evaluation of Pelvic Exenteration in Patients With Recurrent Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 78
- 主要终点
- Overall survival
研究概览
简要总结
This phase II trial is studying how well pelvic exenteration works in treating patients with recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent cervical cancer.
详细描述
PRIMARY OBJECTIVE:
I. Correlate progression-free survival and overall survival with tumor size, time interval between primary cancer management and pelvic exenteration, and presence or absence of pelvic sidewall fixation by clinical examination in patients with recurrent cervical cancer treated with pelvic exenteration.
SECONDARY OBJECTIVES:
I. Determine quality of life of patients treated with this procedure. II. Correlate quality of life with reconstructive technique (e.g., no ostomy or ≥ 1 ostomy) in patients treated with this procedure.
OUTLINE:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cervical cancer
- •Any histology
- •Documented or suspected central pelvic disease with or without pelvic sidewall fixation from tumor and/or radiation fibrosis
- •Meets 1 of the following stage criteria:
- •Recurrent disease, defined as reappearance of disease after a complete clinical response lasting ≥ 1 month
- •Persistent disease, defined as presence of disease by biopsy ≥ 3 months after completion of primary therapy
- •Must have received prior primary treatment, including any of the following:
- •Surgery with or without post operative radiotherapy with or without chemotherapy
- •Primary radiotherapy with or without chemotherapy
- •Neoadjuvant chemotherapy followed by surgery
- •Neoadjuvant chemotherapy followed by surgery with or without radiotherapy or chemotherapy
- •Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry
- •Deemed to be a good surgical candidate
- •No evidence of distant disease or disease that is felt to be unresectable by physical examination
- •Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease are eligible at the discretion of the surgeon
- •Patients whose surgery is planned solely for managing complications (e.g., rectovaginal fistula, vesicovaginal fistula) of disease or prior therapy are not eligible
- •Patients whose surgery is planned as a prophylactic measure due to a slow or suboptimal clinical or radiographical tumor response during the course of primary therapy are not eligible
- •No distant site of metastases by CT scan or MRI of the abdomen/pelvis OR positron-emission tomography
- •No noncervical primary tumor
- •No prior anterior or posterior pelvic exenteration
排除标准
- 未提供
结局指标
主要结局
Overall survival
时间窗: From entry to protocol to death; or for living patients, the date of last contact, up to 93 years
Progression-free survival
时间窗: From study entry to date of reappearance or increasing parameters of disease or death, or to date of last contact for patients without disease progression, up to 93 years
次要结局
- Impact of surgery therapy (exenteration and reconstructive surgery type) on quality of life assessed by Functional Assessment of Cancer Therapy-Cervix (FACT-CX)(At baseline, 6, 12, and 24 months post exenteration)