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临床试验/NCT01853059
NCT01853059Unknown不适用

Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus

Cambridge University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
176
试验地点
2
主要终点
Functional quality of life after chemoradiotherapy for anal cancer

研究概览

简要总结

Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This is very successful (75% long term survival). During the course of the radiotherapy, other organs in the pelvis may be damaged. This can lead to long-term problems with possible changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered help with these side effects. At present, there is very little information on the effect treatment has on a patient's quality of life, making it difficult to judge if new treatment methods are better.

This project will measure quality of life from the patient's perspective after treatment for anal cancer. It will also gather preliminary data on quality of life after the introduction of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called IMRT.

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
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Squamous cell or basaloid carcinoma of the anal canal

排除标准

  • adenocarcinoma, melanoma, lymphoma, sarcoma or other malignancy of anal canal
  • Any synchronous or metanchronous pelvic malignancy of non-anal origin (eg. prostatic, genital tract)
  • unable to complete questionnaire

结局指标

主要结局

Functional quality of life after chemoradiotherapy for anal cancer

时间窗: 3 years

Quality of life measured using: General * EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 Disease specific * EORTC QLQ-CR29 * Vaizey incontinence score * MOS (Medical Outcomes Survey) sexual questionnaire

次要结局

  • Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Stearns

Specialist Registrar in Surgery

Cambridge University Hospitals NHS Foundation Trust

研究点 (2)

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