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临床试验/NCT00193934
NCT00193934已完成不适用

Prospective Study to Determine the Relationships Between Survival and FIGO Stage, Tumour Volume and Corpus Invasion in Cervical Cancer

Trans Tasman Radiation Oncology Group16 个研究点 分布在 5 个国家目标入组 109 人开始时间: 2006年1月最近更新:
适应症

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

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

发起方
Trans Tasman Radiation Oncology Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

TROG Administrator

Rebecca Montgomery

Trans Tasman Radiation Oncology Group

研究点 (16)

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