Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy - Prospective, Randomized, Two-armed Phase-II-study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence and grade of vaginal fibrosis
研究概览
简要总结
A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of <20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of >35-49% as Grade 3 and a reduction >/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.
详细描述
The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Female patient
- •Histologically confirmed squamous anal cancer
- •Indication for definitive or postoperative radiotherapy
- •Age > 18 years
- •Written informed consent
排除标准
- •patients refusal or incapability of informed consent
- •no vaginal dilatation possible prior to radiation treatment start
- •prior pelvic irradiation (if direct field border or even overlap of radiation fields assumed)
- •participation in another clinical trial which might influence the results of the DILANA trial
- •pregnancy/nursing period or inadequate contraception in women with child bearing potential
研究组 & 干预措施
Tampon with extended vaginal dilatation
Patients in arm A will use a special tampon with extended vaginal dilatation during radiotherapy
干预措施: special tampon with a diameter of 28mm (Device)
Commercially available tampon
Patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
干预措施: standard tampon with a diameter of 12-13mm (Device)
结局指标
主要结局
incidence and grade of vaginal fibrosis
时间窗: Up to 12 months after start of (chemo)radiotherapy
during and after radiotherapy, clinical symptoms are assessed and graded
次要结局
- assessment of the compliance for the use of a vaginal dilatator(continously at every follow-up visit)
- clinical symptoms and toxicity according to the CTC AE version 5.0. criteria(weekly during radiotherapy, at each follow-up visit)
- clinical feasibility of daily use of a special tampon(continously during radiotherapy)
- assessment of quality of life(baseline, 6-8 weeks after and 6/12 months after finishing radiotherapy)
研究者
Juergen Debus
Principal Ivestigator
University Hospital Heidelberg