NCT01680523Unknown不适用
A Randomized Controlled Trial Comparing Radical Hysterectomy Plus Tailored Adjuvant Therapy Versus Primary Chemoradiation Therapy in Bulky Early-stage Cervical Cancer (KGOG 1029)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 409
- 试验地点
- 2
- 主要终点
- 5-year overall survival
研究概览
简要总结
To compare 5-year overall survival between patients who undergo radical hysterectomy followed by tailored adjuvant therapy and patients who receive primary chemoradiation therapy in FIGO stage IB2 and IIA2 cervical cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previously untreated, histologically confirmed cervical cancer
- •FIGO stage IB2 and IIA2 disease
- •One of following histologic types
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Adenosquamous carcinoma
- •Gynecologic Oncology Group performance status: 0-2
- •Adequate organ function
- •Bone marrow: WBC > 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin ≥ 10g/dL
- •Kidney: Creatine < 1.25 * upper normal limit
- •Liver: AST, ANT < 3 * upper normal limit, Total bilirubin < 1.5 mg/mm3
- •Patient who have Singed an approved informed consent
排除标准
- •Patients with cervical cancer who have received any previous radiation or chemotherapy
- •Neuroendocrine carcinoma of uterine cervix
- •Occult cervical cancer which was found after simple hysterectomy
- •Para-aortic nodal involvement (> 10 mm short axis diameter on pretreatment imaging study)
- •History of other invasive malignancies, with the exception of non-melanoma skin cancer, in situ melanoma and thyroid cancer, who had (or have) no evidence of the other cancer present within the last 5 years
- •Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Prior diagnosis of Crohn's disease or ulcerative colitis
- •Neurologic or psychiatric disease
- •Patients who are pregnant or lactating
结局指标
主要结局
5-year overall survival
时间窗: 5 year after treatment
次要结局
- 5-year progression-free survival(5 years after treatment)
- Pattern of disease recurrence(within 5 years afer treatment)
- Treatment-related toxicity(within 5 years after treatment)
- Quality of life(within 1 year after treatment)
研究者
Joo-Hyun Nam
Professor
Asan Medical Center
研究点 (2)
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