NCT02785263已完成不适用
Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- The fraction of enrolled patients wanting to take part in the decision making on radiation dose level
研究概览
简要总结
The purpose of this study is to maximize patient involvement in the treatment of anal cancer. Specifically, the investigators will investigate whether patients wish to take part in the decision making on radiation dose and whether they want a high or low radiation dose.
详细描述
The study will also provide new knowledge on the effect and side effects of irradiation of anal cancer, and detailed data from the dose planning will be instrumental in optimizing future decision aids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Squamous cell carcinoma of the anal duct or perianal (non-hairy skin, max 5 cm from the anal verge)
- •T2-T4 N0-3
- •Age ≥ 18 years
- •Performance status 0-2
- •Sufficient organ and bone marrow function defined as:
- •Neutrophils ≥ 1.5 x 10^9/L
- •Thrombocytes ≥ 100 x 10^9/L
- •Curative intent radiation treatment deemed possible
- •Patients chooses 1 of 3 options:
- •I do not wish to decide on details of my treatment, but I would like to receive the standard treatment
- •I want to receive the high radiation dose
- •I want to receive the low radiation dose
- •Written and orally informed consent
排除标准
- •Non-resectable metastases
- •Tumor > 10 cm or the total tumor volume (incl. lymph node metastases) is too large to be included in an appropriate radiation field (after possible neoadjuvant chemotherapy)
- •Pregnant or breastfeeding women
- •Fertile women not willing to use effective contraception
- •Serious co-morbidity that would hinder interfere with radiation treatment or hinder patient compliance (e.g. incapacity to understand or complete questionnaires)
结局指标
主要结局
The fraction of enrolled patients wanting to take part in the decision making on radiation dose level
时间窗: 6 months after the last patient has finished radiotherapy
The fraction of enrolled patients choosing the lower radiation dose
时间窗: 6 months after the last patient has finished radiotherapy
次要结局
- Number of patients with a V35Gy of less than 75% for the bladder calculated on the basis of dose plans(6 months after the last patient has finished radiotherapy)
- Number of patients with loco-regional recurrence 60 months after end of treatment(5 years after inclusion of the last patient)
- Colostomy free survival(5 years after inclusion of the last patient)
- Number of patients with treatment related adverse events as assessed by healthcare staff based on the common toxicity criteria (CTCAE v.4.0)(5 years after inclusion of the last patient)
- Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29(5 years after inclusion of the last patient)
- Overall survival(5 years after inclusion of the last patient)
- Number of patients with a V45Gy of less than 300 cc for the small bowel calculated on the basis of dose plans(6 months after the last patient has finished radiotherapy)
- Subjective symptoms as assessed by LARS score (low anterior resection syndrome)(5 years after inclusion of the last patient)
- Disease free survival(5 years after inclusion of the last patient)
- Response evaluation assessed by diffusion weighted imaging(6 months after the last patient has finished radiotherapy)
- Number of patients with HPV at time of enrollment(6 months after the last patient has finished radiotherapy)
- Rate of complete response(6 months after the last patient has finished radiotherapy)
- Number of patients with distant metastases at 5 years(5 years after inclusion of the last patient)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
Anal Cancer Radiotherapy StudyAnal CancerNCT01937780Oslo University Hospital75
招募中
不适用
Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).Anal Cancer PatientsNCT06364579Fondazione Policlinico Universitario Agostino Gemelli IRCCS120
招募中
不适用
IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal CancerMalignant Neoplasm of Anal CanalNCT06630793Tata Memorial Centre108
招募中
2 期
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized ApproachAnal Squamous Cell CarcinomaNCT06050707University Health Network, Toronto80
终止
1 期
Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal CancerAnal CancerNCT01324141National Cancer Institute (NCI)6