Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma - Swedish Anal Carcinoma Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Acute grade >2 hematological side effects
研究概览
简要总结
Dosimetric studies suggest that radiotherapy with protons has a potential to reduce side effects compared to treatment with photons for patients with anal carcinoma (AC). There are so far no studies comparing these treatment techniques in a randomised setting. The aim of this study is to compare side effects following photon therapy versus proton therapy within the framework of a randomised controlled trial.
详细描述
Anal carcinoma is a disease in which modern therapy is reasonably successful in achieving tumour control/cure. Both acute and late side effects are substantial. Proton radiotherapy is hypothesised to have the potential to decrease the incidence/severity of some acute side effects from certain organs at risk e.g. bone marrow and intraperitoneal bowel. By sparing the dose to these organs it is also possible that late effects might be less evident. Sparing of the bone marrow may lead to fewer septic events and dose reductions of chemotherapy which may, as a consequence, improve tumour control. The primary aim of this study is to find ways to decrease acute side effects primarily to alleviate some discomfort from the patient during and after a usually painful treatment experience. It has also been concluded by others that reduction of acute side effects is a relevant aim and end point for the evaluation of new treatment techniques and both patient reported and physician reported data are assessed
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •The patient must be at least 18 years old
- •Histologically confirmed, previously untreated squamous cell carcinoma (p16-positive or p16-negative) of the anal canal (ICD-O-3 C21), i.e. cancer of the perianal skin without connection to the anal canal are not included. The patients may have primary tumour, regional nodes, metastasis (TNM)-stage T2 (>4 cm) -4,N0-1c,M0 (UICC 8th edition).
- •World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1
- •The patient must be able to understand the information about the treatment and give a written informed consent.
排除标准
- •Patients with cancer of the perianal skin without involvement of the anal canal (ICD-O-3 C44.5) are not eligible.
- •Patient judged to have any other treatment than radiotherapy with concomitant chemotherapy as the preferred treatment
- •Concomitant or previous malignancies. Exceptions are, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or, other previous malignancy with a disease-free interval of at least 5 years.
- •Two or more synchronous primary cancers in the pelvic region at time of diagnosis
- •Previous radiotherapy, surgery or chemotherapy that may interfere with the planned treatment for the present disease, as judged by the investigator.
- •Co-existing disease prejudicing survival (expected survival should be >2 years).
- •Pregnancy or breast feeding
- •When prosthetic materials (e.g. hip prostheses) are present close to the target volume it must be considered if this may introduce uncertainties in dose calculations that precludes especially, proton therapy.
- •Patients with pacemaker/ICD are not eligible.
结局指标
主要结局
Acute grade >2 hematological side effects
时间窗: Treatment start until three months after treatment
Acute hematological side effects will be assessed by weekly full blood cell counts during radiotherapy and the first three weeks after treatment completion. Side Grade \>2 acute GI and haematological side-effects during therapy and up to three weeks after the end of treatment. Thereafter, every six weeks for up to three months after treatment. Results will be graded according to the Common Terminology Criteria for Adverse Events (NTCAE) v5.0 scoring system. Haematological adverse events will also be assessed by registering febrile episodes during an after treatment as well as the frequency of chemotherapy dose reduction or delayed chemotherapy.
次要结局
- Locoregional failure(Up to five years after randomisation)
- Overall survival(Up to five years after randomisation)
- Acute side effects from skin(Treatment start until three months after treatment)
- Late side effects from the gastro-intestinal system(From three months after treatment up to five years after treatment)
- Late side effects from skin(From three months after treatment up to five years after treatment)
- Assessment of Quality of life (QoL)(From randomisation up to 5 years)
- Pain due to acute radiation reaction(Treatment start until three months after treatment)
- Late side effects(From three months after treatment up to five years after treatment)
- Acute grade >2 gastrointestinal side effects(Treatment start until three months after treatment)
- Acute side effects from the genitourinary tract(Treatment start until three months after treatment)
- Primary tumour response(3-6 months after treatment)
- Disease free survival(Up to five years after randomisation)