Chemo- and Radiotherapy in Epithelial Vulvar Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,618
- 试验地点
- 1
- 主要终点
- Determination of several specific characteristics
研究概览
简要总结
This retrospective, multicenter study is designed to collect tumor characteristics as well as treatment data from patients diagnosed with primary or recurrent squamous cell cancer of the vulva with emphasis on indication and application of radio- and chemotherapy. Application of chemotherapy in primary treatment of vulvar cancer is rare; the study collective is therefore extended to relapsed disease.
详细描述
All patients with primary squamous cell cancer of the vulva > stage Ia who were diagnosed and received treatment between 1998 and 2008 at the participating centres will be included in the study. Furthermore patients with recurrent disease diagnosed and treated at the participating centres during the same time period can be included given that they not only underwent surgical excision for treatment.
For centers with restricted resources for data entry an alternative study collective was defined:
All Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment at the participating centres between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radio/chemotherapy for other reasons.
The participating centers themselves have to decide which study collective they are documenting, dependent on their available resources.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with primary squamous cell vulvar cancer except stage Ia disease regardless of the received treatment
- •Patients with recurrent squamous cell vulvar cancer, if the relapse was not only treated with a surgical excision.
- •Or alternatively, dependent on the decision of the participating center:
- •Patients with primary or relapsed squamous cell vulvar cancer receiving radio- and/or chemotherapy for treatment regardless of nodal involvement.
- •Patients who were diagnosed with and treated for primary or relapsed vulvar cancer between 1998 and 2008
- •Women aged ≥ 18 years
排除标准
- •Patients with benign or precursor lesions (VIN - vulvar intraepithelial neoplasia) of the vulva
- •Patients with non-squamous neoplasia of the vulva (e.g. melanoma)
- •Patients with verrucous vulvar cancer
- •Patients with relapsed squamous cell vulvar cancer only receiving surgical excision for treatment.
- •Patients with secondary cancers if those interfered with the treatment of vulvar disease
结局指标
主要结局
Determination of several specific characteristics
时间窗: Data from vulvar cancer pts between 1998 and 2008 will be included in the study. This also includes node negative patients receiving radi
* Determination of the fraction of node positive patients to estimate the number of participating centers and sample size for a subsequent prospective trial. * Determination of the prognostic impact of the number of positive lymph nodes and the stage of disease to define indication criteria for adjuvant radio/chemotherapy for a subsequent prospective trial. * Identification of indication criteria for adjuvant/therapeutic/palliative radio/chemotherapy
次要结局
未报告次要终点