Prospective, Randomised and Multi-centric Therapy Optimisation Study for Examining the Influence of Surgical Staging on the Oncological Results for Patients With Cervix Carcinoma of the FIGO Stages IIB-IV After Chemoradiation
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- DFS (disease-free survival)
研究概览
简要总结
The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.
详细描述
The aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the FIGO stages IIB-IV prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.
To this end, 250 patients with histologically verified cancer of the cervix uteri of the stages IIB-IV shall be randomised to a standard arm (ARM B), whereby the therapy shall be conducted on the basis of the clinical FIGO stage.
The patients randomised to the test arm (Arm A), after determining the clinical FIGO stage, shall initially receive an operative staging in the form of a pelvine paraaortal lymphadenectomy (laparoscopic or open). On the basis of the operatively obtained findings, a ("surgically") modified tumour stage shall be determined. This "surgical" tumour stage, which shall take into account the affection of the lymph nodes, the infiltration of the neighbouring organs and the intraperitoneal spread, shall serve as the basis for the execution of primary, combined radio-chemotherapy. The primary end-point is the disease-free survival of both groups, the secondary endpoints are overall survival, the local control of both groups, as well as the determination of toxicity and the quality of life.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Karnofsky-Index =/> 70,
- •age between 18 - 70 years
- •histological assured cervical cancer (by biopsy)
- •FIGO stages II B - IV
- •written informed consent
- •patient's ability to cooperate
排除标准
- •neuroendocrine tumors or histological mixed types containing neuroendocrine fractions
- •pregnancy, lactation,
- •distant metastases, except paraaortal metastases
- •other malignant diseases in anamnesis
- •pelvic radiotherapy in anamnesis
- •severe internal diseases
- •psychiatric diseases which might query the trial attendance or follow-up
- •HIV-Infection or AIDS
- •drug addiction
- •existing motoric or sensoric polyneuropathy > CTC Grad 1
研究组 & 干预措施
operative staging (A)
operative staging and systemic lymphadenectomy, paraaortal and pelvine, laparoscopic or open
干预措施: lymphadenectomy (Procedure)
Standard (B)
No surgical intervention. Clinical Staging (FIGO) CT Abdomen / pelvic enlarged or suspicious lymphnodes--> CT controlled biopsy and histological analysis.
干预措施: Standard Staging (Other)
结局指标
主要结局
DFS (disease-free survival)
时间窗: 4 years
次要结局
- OS, LC, QOL (overall survival, local control,quality of life, the determination of toxicity)(4 years)