MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Change in locoregional failure (LRF) at Year 2
研究概览
简要总结
The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a risk-stratified dose of treatment (radiation dose and chemotherapy number of cycles) based on predefined clinical and biological biomarkers for anal squamous cell carcinoma (SCC). Radiotherapy will be delivered on the MR-Linac for image-guided-radiation therapy (IGRT). Patients will be followed for up to 5 years after radiotherapy and be required to complete questionnaires and clinic visits. Patients have the option to complete blood and tissue samples during the study.
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 pathologically proven diagnosis of anal SCC. This may include tumors of non-keratinizing histology such as basoloid or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible.
- •Clinical stage T1-4 N0-1 M0 (the Union for International Cancer Control (UICC) / the American Joint Committee on Cancer (AJCC) 8th Ed)
- •Patients must be eligible for definitive RT or CRT
- •Must be ≥ 18 years of age
- •Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
排除标准
- •Previous chemotherapy, RT or curative-intent surgical treatment (i.e. APR) for anal cancer.
- •Any previous RT to the abdomino-pelvic region that would result in overlap of RT volume for the current study.
- •Individuals with a history of a different malignancy except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
结局指标
主要结局
Change in locoregional failure (LRF) at Year 2
时间窗: 2 years
Any local or regional failure from the date of registration to the date of any of the local or regional failure.
次要结局
- Presence of distant metastasis (DM)(5 years)
- Colostomy rate(5 years)
- Disease free survival (DFS)(5 years)
- Overall survival (OS)(5 years)
- Physician-reported toxicities(5 years)
- Patient Reported Outcomes(5 years)
- Quality of life (QOL)(5 years)