Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 16
- 主要终点
- Assess the prognostic significance, with respect to overall survival, of the factors, FIGO stage. Overall survival is defined as the date of registration to date of death from any cause.
研究概览
简要总结
The researchers propose that it may be corpus invasion, rather than tumour volume per se, which is one of the important determinants of ultimate outcome in cervix cancer. The aim of the proposed prospective, multicentre study, is to confirm the results of our retrospective studies, specifically that corpus invasion or tumour volume or both contribute important prognostic information over and above that provided by the currently used International Federation of Gynecology and Obstetrics (FIGO) staging system. A successful outcome would have important implications for the staging, and management as well as the biologic understanding of the behaviour of cervical cancer.
详细描述
This will be a prospective, multicentre, prognostic factor, follow-up study. The study is designed to be as simple as possible: newly diagnosed cervical cancer patients will have key prognostic variables collected at baseline. The treatment received will be documented at the end of treatment and patients will then be followed for first relapse and survival.
Registration of a patient on this study can be undertaken after EUA, biopsy confirmed diagnosis, anatomic staging diagram and MRI have been done and before any treatment has commenced.
Treatment must be curative in intent (termed radical therapy) but otherwise can be at the discretion of the investigator. Radical hysterectomy alone, hysterectomy followed by adjuvant radiotherapy, radical chemo-radiotherapy or radical radiotherapy will be allowed. Details of the planned and given treatment regimen will be recorded.
All patients will have the following trial data documented at the time of registration:
- Age
- ECOG performance status
- smoking status
- date of histological diagnosis
- histologic type and features
- presenting haemoglobin
- standard FIGO staging
- maximum clinical tumour diameter measured at EUA
- detailed staging diagram drawn at EUA
- nodal status (by surgical pathology or CT or MRI or both and PET if available)
- date of MRI
- MRI tumour diameters
- presence or absence of corpus invasion on MRI
- planned treatment details
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Newly diagnosed, biopsy proven carcinoma of the uterine cervix.
- •Squamous cell, adenocarcinoma, adenosquamous or large cell carcinoma histology.
- •FIGO Stage Ib -IVa.
- •Maximum clinical tumour diameter recorded.
- •MRI done within 30 days prior to registration.
- •Intention to treat radically
- •Treatment not yet started.
- •Written informed consent.
- •Available for follow-up.
排除标准
- •Lymphoma, small cell carcinoma and melanoma histology.
- •Previous hysterectomy
结局指标
主要结局
Assess the prognostic significance, with respect to overall survival, of the factors, FIGO stage. Overall survival is defined as the date of registration to date of death from any cause.
时间窗: End of study
次要结局
未报告次要终点
研究者
TROG Administrator
Rebecca Montgomery
Trans Tasman Radiation Oncology Group
