Observational Study of Functional Outcomes After Chemoradiotherapy for Squamous Cell Cancer of the Anus
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
- 否
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
Adam Stearns
Specialist Registrar in Surgery
Cambridge University Hospitals NHS Foundation Trust
