Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management

Официальное название

Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management - a Randomised Feasibility Study

Обзор

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

Подробное описание

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

STUDY DESIGN

* Randomised 1:1 * The study is unblinded for the trial investigators and participants.

VISITS (in line with routine standard care):

* 1 Pre-treatment appointment * 1 CT planning scan (immobilisation/mould room as required dependent on anatomical site) * 10 radiotherapy treatment appointments (Control Arm) / 5 radiotherapy treatment appointments (Experimental Arm) * 2 on-treat clinic reviews (week 1 and week 2) * End of Treatment/Safety follow up (4 weeks post-radiotherapy) * Follow-up at 3 months, 6 months, and 12 months

INVESTIGATIONS

* Quality of Life questionnaires * Blood tests * Clinical/Physical Examination

Вмешательства

• Процедура radiotherapy
  External Beam Radiotherapy - hypofractionated, short radiotherapy regime of 30Gy in 5 fractions (6Gy per fraction) delivered on alternate days over 2 weeks

Первичные конечные точки

• Primary Outcome [Срок оценки: 24 months]

Вторичные конечные точки (3)

• Secondary aim [Срок оценки: 24 months]
• Secondary aim [Срок оценки: 24 months]
• Secondary aim [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• The Royal Marsden NHSFT — London

Идентификаторы

NCT: NCT06995664 · CCR5652

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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