Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management - a Randomised Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
Prospective, randomised, feasibility study of patients with localised or metastatic renal cell carcinoma (RCC) comparing standard palliative dose radiotherapy to a high-dose hypofractionated regime.
Primary aim
• To demonstrate feasibility of a randomised study comparing high-dose hypofractionated radiotherapy versus standard palliative dose radiotherapy in localised or metastatic renal cell carcinoma The aim is to recruit a minimum of 24 patients; 12 to the control arm and 12 to the high-dose regime.
2 treatment arms, no placebo:
- Control arm - standard palliative-dose radiotherapy, 30Gy in 10 fractions in 3Gy per fraction over 2 weeks
- High-dose arm - high-dose radiotherapy, 30Gy in 5 fractions in 6Gy per fraction on alternate days/2-3 fractions a week over 2 weeks
详细描述
HYPOTHESIS The investigators hypothesise that it is feasible to recruit to a study of localised and metastatic renal cell carcinoma comparing a high-dose short fractionation radiotherapy regime (30Gy in 5 fractions in alternate day fractions over 2 weeks) in comparison to the standard palliative dose-fractionation (30Gy in 10 fractions in daily fractions over 2 weeks).
AIMS Primary aim
• To demonstrate feasibility of a randomised study comparing high-dose hypofractionated radiotherapy versus standard palliative dose radiotherapy in localised or metastatic renal cell carcinoma
Secondary aim
- To report acute and late toxicity in both treatment groups
- To demonstrate completion of quality of life (QOL) validated EORTC forms by patients under study
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
盲法说明
Unblinded to investigator and participants
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
- •Histologically confirmed renal cell carcinoma (RCC) (histological confirmation of metastasis not required) or clinically consistent with RCC as per multidisciplinary team (MDT) diagnosis.
- •Not suitable for surgical resection, metastasectomy or ablative therapy due to tumour or patient factors
- •All extracranial sites which clinically require radiotherapy (as per clinician discretion)
- •Age ≥18 years
- •Karnofsky Performance Status (KPS) ≥50
- •Adequate baseline organ function applicable to site-of irradiation
- •Haemaglobin ≥90g/dl
- •Platelets ≥50
- •Bilirubin <3x ULN
- •INR <1.4 or correctable with vitamin K
- •AST or ALT <5x normal range
- •Creatinine <200umol/L (or established on dialysis). Note patients on dialysis are unable to have dynamic contrast enhanced MRI.
- •The use of concurrent systemic therapy is acceptable
- •Ability of the research subject to understand and the willingness to sign a written informed consent document
- •Able to undergo all mandated staging and follow-up investigations
- •Negative pregnancy test (for women of childbearing potential)
排除标准
- •Expected prognosis <6 months
- •Uncontrolled intracranial metastases
- •Previous radiotherapy, such that the delivery of further radiotherapy is not feasible
- •Unable to have necessary radiotherapy planning, radiotherapy related investigations/fiducials (if required)
- •Co-morbidities or any psychological, familial, sociological or geographical condition which may preclude ability to undergo/attend investigations, treatment or follow-up
- •Other active primary cancer
- •Pregnant or lactating
- •Requiring ongoing treatment with a concomitant medication, which is contraindicated alongside radiotherapy (e.g. methotrexate)
研究组 & 干预措施
Control
Standard palliative-dose radiotherapy, 30Gy in 10 fractions in 3Gy per fraction over 2 weeks
Experimental / High-dose
High-dose radiotherapy, 30Gy in 5 fractions in 6Gy per fraction on alternate days/2-3 fractions a week over 2 weeks
干预措施: radiotherapy (Procedure)
结局指标
主要结局
Primary Outcome
时间窗: 24 months
To demonstrate feasibility of recruitment (assessed by 35% of eligible patients accepting the offer of recruitment). To calculate the proportion of patients that accept the offer of recruitment to the study. The denominator is the number of eligible patients that have been approached for the study
次要结局
- Secondary aim(24 months)