Bone-sparing Chemoradiotherapy for Anal Cancer - A Prospective Phase II Trial Danish Anal Cancer Group Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rate of PIFs
研究概览
简要总结
This study proposal includes a prospective clinical trial of bone sparing treatment planning in anal cancer patients. the trial aim to lower the risk of bone damage, while adhering with the constrains to the bowel, bladder and other conventional Organs At Risk, and finally to describe the fraction of pelvic insufficiency fractures in patients treated with optimized radiotherapy.
详细描述
Patients will receive standard (chemo)-radiotherapy according to national Danish Anal Cancer Group (DACG) guidelines, but the bone-sparing focus will be added to the algorithm for dose-constrains and planning objectives. A bone specific magnetic resonance scan will be performed at 1 year post treatment. Additional substudies include collection of blood samples for translational research purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with biopsy verified localized squamous cell anal cancer
- •Indication for standard (chemo)-radiotherapy with curative intend for anal cancer as per multidisciplinary team decision
- •Clinical eligible for standard (chemo)-radiotherapy as per physicians' decision
- •Written and oral consent
- •Age at least 18 years
排除标准
- •Previous pelvic radiotherapy
- •Previous systemic therapy with severe bone marrow suppression or hematological diseases
- •Hip-replacements
- •Contraindications to MRI-scan
结局指标
主要结局
Rate of PIFs
时间窗: 1 year
Rate of pelvic insufficience fractures (PIF) on MRI
次要结局
- Rate of symptomatic PIFs(after 1 and 3 year)
- Predictive and prognostic biomarkers(Pre-treatment, By end of therapy (on average 30 days) and after 1 and 3 years)
- Rate of toxicity from standard organs at risk (OAR)(after 1 and 3 years)
- Patient reported outcomes measures (LARS)(Pretreatment and at 1 and 3 years)
- Patient reported outcome measures (FACT-BP)(Pretreatment and after 1 and 3 years)
- Quality of Life measures (EORTC)(Pretreatment and after 1 and 3 years)
研究者
Karen-Lise Garm Spindler
Professor
Aarhus University Hospital