Conservative Surgery for Women With Low-Risk, Early Stage Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 137
- 试验地点
- 35
- 主要终点
- Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
研究概览
简要总结
This clinical trial studies conservative surgery in treating patients with low-risk stage IA2 or IB1 cervical cancer. Conservative surgery is a less invasive type of surgery for early stage cervical cancer and may have fewer side effects and improve recovery.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the safety and feasibility of performing conservative surgery in women with stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features.
SECONDARY OBJECTIVES:
I. To estimate the cervix cancer recurrence rate at 2 years in women treated with conservative surgery for stage IA2 or IB1 carcinoma of the cervix with favorable pathologic features.
II. To compare pelvic lymph node involvement in patients undergoing conservative surgery with historical data from matched patients treated with radical hysterectomy.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1 or 2 adenocarcinoma of cervix
- •International Federation of Gynecology and Obstetrics (FIGO) stage IA2 or IB1 disease
- •Tumor diameter =< 2 cm on physical exam and on imaging studies
- •No lymphovascular space invasion (LVSI) present on biopsy or previous cone
- •Less than 10 mm of cervical stromal invasion
- •Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) II, CIN III or adenocarcinoma-in-situ; (a negative margin is defined as no invasive cancer within 1.0 mm of both the endocervical and ectocervical margins and no adenocarcinoma in situ [AIS] or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted)
- •Patients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met; the cone and ECC must be performed within 12 weeks prior to pre-enrollment in the study; if the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed 1 repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteria
- •Patients must sign an approved informed consent document
- •If patient is of childbearing potential, she must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study
- •Imaging with positron emission tomography (PET) scan, computed tomography (CT) scan of the abdomen and pelvis, and/or magnetic resonance imaging (MRI) of the abdomen and pelvis must be performed and negative for metastatic disease within 12 weeks of enrollment
排除标准
- •Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies
- •Grade 3 adenocarcinoma
- •FIGO stage IA1, IB2, II, III or IV disease
- •Tumors > 2 cm in diameter on physical exam or imaging studies
- •Presence of LVSI
- •Greater than or equal to 10 mm of cervical stromal invasion
- •Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted)
- •Neoadjuvant radiation therapy or chemotherapy for cervical cancer
- •Patients unwilling or unable to provide informed consent for the study
- •Evidence of metastatic disease on PET, CT, and/or MRI performed within 12 weeks of enrollment
- •Patients who have had a simple hysterectomy (cut through hysterectomy)
研究组 & 干预措施
Treatment (conservative surgery)
Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.
干预措施: Lymph Node Mapping (Procedure)
Treatment (conservative surgery)
Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.
干预措施: Quality-of-Life Assessment (Other)
Treatment (conservative surgery)
Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.
干预措施: Salpingo-Oophorectomy (Procedure)
Treatment (conservative surgery)
Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.
干预措施: Sentinel Lymph Node Biopsy (Procedure)
Treatment (conservative surgery)
Patients undergo a complete lymphatic mapping with sentinel lymph node biopsy and/or pelvic lymph node dissection. If future fertility is no longer desired, patients also undergo hysterectomy with or without bilateral salpingo-oophorectomy.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Safety and Feasibility of Performing Conservative Surgery in Women With Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features
时间窗: Approximately 9 years
The proposed treatment strategy will be considered not feasible if the immediate failure rate is more than 3%. The immediate failure rate, defined as residual disease in the simple hysterectomy specimen of women who underwent conization followed by simple hysterectomy and lymph node assessment.
次要结局
- Cervix Cancer Recurrence Rate at 2 Years in Women Treated With Conservative Surgery for Stage IA2 or IB1 Carcinoma of the Cervix With Favorable Pathologic Features(2 years)
- Number of Participants With All-Cause Mortality(Approximately 9 years)