Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 52
- 主要终点
- Relapse Free Survival (RFS)
研究概览
简要总结
Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma
详细描述
International, multicenter, comparative, open-label, parallel-group, mixed Observational-Randomized Controlled Trial.
All the patients, who are candidate for the study will receive full information on the characteristics, potential effectiveness and side effects of the two alternatives treatments: radiotherapy (RT) and surgical treatment Eligible patients will be asked to be randomized in order to receive treatment A (surgery, with or without RT) or treatment B (definitive RT) Who will refuse randomization will be included in the Prospective Cohort Study (PCS) and will be treated accordingly to their choice (treatment option A or treatment option B).
The same radiotherapy and surgical regimen will be administered in the PCS and in the Randomized Clinical Trial (RCT) cohort
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx.
- •Age≥18years
- •ECOG-performance status (PS) 0-2
- •No previous antineoplastic therapy
- •Macroscopic tumor detectable at MRI/CT scan
- •Patient amenable for surgery
- •Patient amenable for RT
- •Written informed consent given before the enrolment, according to International Conference on Harmonisation/good clinical practice (ICH/GCP).
排除标准
- •Distant metastasis
- •Inability to maintain treatment position
- •Prior radiotherapy to the pelvic region
- •Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)
- •Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field)
- •Rectal wall infiltration
- •General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria)
- •Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia)
- •Severe comorbidities resulting in a prognosis of less than 6 months
- •Inability to give informed consent
- •Other malignancy within the last 5 years
- •Performance status ≥ 2 (ECOG).
- •Significant cardiovascular disease (for example, dyspnea > 2 NYHA)
- •Significant systemic diseases grade >3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity
- •Women who are pregnant or breast-feeding
- •Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent
结局指标
主要结局
Relapse Free Survival (RFS)
时间窗: 5 years
The time from randomization or treatment start date to the date of local disease relapse, distant disease relapse, second primary malignancy or death from any cause, whichever occurred first.
次要结局
- Survival Post Progression (SPP)(Expected average: 36 months)
- Local Relapse Failure (LRF)(Expected average: 60 months)
- Distant Relapse Failure (DRF)(Expected average: 60 months)
- Time to best response rate to definitive radiotherapy(At 12 months, 2 years and 5 years after radiotherapy)
- Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General(every 6 months (expected average: 5 years))
- Best Response rate to definitive radiotherapy(At 12 months, 2 years and 5 years after radiotherapy)
- Evaluation of quality of life measured with Brief Inventory Pain questionnaires(every 6 months (expected average: 5 years))
- Adverse Events Incidence(At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy)
- Overall Survival (OS)(The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years))