Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy With Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (≤ 2CM) Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 224
- 试验地点
- 369
- 主要终点
- Change in bladder and bowel function score based on supplemental bladder and bowel questions plus 4 items from the Functional Assessment of Cancer Therapy-Cervix (3 bladder and 1 bowel question)
研究概览
简要总结
This clinical trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects of surgery.
详细描述
PRIMARY OBJECTIVES:
I. To examine the changes before and after non-radical surgical treatment (simple hysterectomy or cone biopsy [fertility preservation] and pelvic lymphadenectomy) on functional outcomes of bladder, bowel, and sexual function for stage IA1 (lymphatic vessel invasion positive [LVSI+]) and IA2-IB1 (=< 2 cm) carcinoma of the cervix.
II. To evaluate incidence and severity of lymphedema after non-radical surgery (simple hysterectomy or cone biopsy [fertility preservation] and pelvic lymphadenectomy) for stage IA1 (LVSI+) and IA2-IB1 (=< 2 cm) carcinoma of the cervix.
SECONDARY OBJECTIVES:
I. To investigate if non-radical surgery (simple hysterectomy or cone biopsy [fertility preservation] with pelvic lymphadenectomy) demonstrates greater physical function and less toxicity in comparison to historical data on radical surgery (radical hysterectomy or radical trachelectomy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patient must consent for the appropriate surgery
- •Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade
- •All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =< 10 mm
- •Patients must have no evidence of metastasis on positron emission tomography (PET) scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the pelvis and chest imaging
- •Patients who have met the pre-entry requirements
- •Patients must have signed an approved informed consent and authorization permitting release of personal health information
- •Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
排除标准
- •Patients with stage IA1 disease who are LVSI negative
- •Patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm
- •Patients with >= stage IB2 disease
- •Patients with clear cell or neuroendocrine cell types
- •Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP)
- •Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
结局指标
主要结局
Change in bladder and bowel function score based on supplemental bladder and bowel questions plus 4 items from the Functional Assessment of Cancer Therapy-Cervix (3 bladder and 1 bowel question)
时间窗: Baseline to 3 years
Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Change in sexual function and activity based on Female Sexual Function Index (19 items) score plus 2 Patient Reported Outcomes Measurement Information System screener items
时间窗: Baseline to 3 years
Analysis of variance methods with repeated measurements and a time component will initially be used to determine whether there are significant changes over time.
Lymphedema
时间窗: Up to 3 years
Based on Cancer Lymphedema Questionnaire score.
Maximum grade and duration of severe adverse events associated with bladder, bowel, and sexual dysfunction and lymphedema
时间窗: Up to 3 years after non-radical surgical procedure
Graded according to Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 will be used staring April 1, 2018).
次要结局
- Maximum grade of treatment-related adverse events(Up to 30 days after surgical procedure)
- Change in overall quality of life(Baseline to 3 years)
- Site of first recurrence(Up to 3 years)
- Change in cancer worries based on Impact of Events score(Baseline to 3 years)
- Change in reproductive concerns based on reproductive concerns (14 items) score(Baseline to 3 years)
- Recurrence-free survival(Up to 3 years)
- Overall survival(Up to 3 years)