EUCTR2019-004053-91-GB进行中（未招募）1 期
Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma - BRIOChe
niversity of Leeds0 个研究点目标入组 70 人开始时间: 2020年5月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically proven diagnosis of GBM with consistent molecular pathology, based on original pathology.
- •First recurrence of GBM, with contrast enhancing disease, following primary treatment (or following surgery alone for first recurrence of GBM; i.e. no previous systemic therapy or re-irradiation for recurrence permitted).
- •The MRI scan that reveals recurrence must be reviewed by the local multi-disciplinary meeting, including agreement of a Consultant Neuro-Radiologist that imaging changes are in keeping with recurrence and not pseudo-progression.
- •Randomisation must be performed within 21 days of the MRI that confirms recurrence. Outside of 21 days, an updated MRI is required to confirm eligibility and serve as a contemporaneous baseline scan to assess response to further treatment. Please see section 9 Assessments for further details for achieving this.
- •=6 months since completion of primary radiotherapy (where the interval since radiotherapy completion is 5 months and 2 weeks or greater, this may be rounded up to 6 months and the patient included in the trial).
- •Prior history of standard dose, conventionally fractionated CNS radiotherapy (i.e. 54-60Gy in 28-33 fractions).
- •As a minimum patients will have completed at least two weeks of temozolomide, concurrent with their original radiotherapy.
- •Up to and including three enhancing lesions:
- •- In cases of a single recurrent enhancing lesion:
- •-predicted re-irradiation GTV<75cm3 (based on diagnostic MR imaging and on maximum diameters of enhancing disease in all 3 planes, calculated from 4/3p x ½ x diameter 1 x ½ x diameter 2 x ½ x diameter 3, and
- •-maximum diameter of enhancing disease must be =6cm. In cases where there is circumferential enhancement around a cavity, such that the cavity and enhancing disease will be included in the GTV, then the maximum diameter of enhancing disease and cavity must be =6cm.
- •-In cases of multiple (i.e. two or three) discrete recurrent enhancing lesions:
- •-the total (i.e. combined) predicted re-irradiation GTV must be <50cm3 and lesions must be clustered in a similar brain region such that PTVs are anticipated to be adjacent or overlapping, and
- •-maximum diameter of combined enhancing disease, across all enhancing lesions (including any gaps between), must be =6cm.
- •Karnofsky Performance Status 70+
- •Adequate hematologic, renal, and hepatic function (absolute neutrophil count, =1.5 x 109/L; platelet count, =100 x 109/L; White cell count =3.0 x 109/L; haemoglobin =10g/L (may be corrected by transfusion); serum creatinine clearance (measured or estimated) =30ml/min; total serum bilirubin level <1.5 times ULN; and ALT <5 times ULN) within 14 days prior to randomisation. (Dose modifications may still be required based on these parameters). Lymphopaenia is not a contra-indication to trial entry.
- •Patients who have had surgery for first recurrence may also be included provided there is residual enhancing disease on the immediate post-operative MRI or if enhancing disease develops on subsequent follow-up imaging, provided no prior systemic therapy or re-irradiation for recurrence has been given. As above, this MRI must be reviewed within the local multi-disciplinary meeting, with agreement of a Consultant Neuro-Radiologist that the imaging changes are in keeping with residual or new enhancing disease. Randomisation must be performed within 21 days of the MRI that confirms re
排除标准
- •Pregnant (positive pregnancy test) or lactating.
- •Critical normal brain structures treated above usual tolerance during initial radiotherapy (i.e. based on 30 fractions initial treatment, >55Gy delivered to 1% or 0.1cm3 of optic nerve or chiasm or >55Gy delivered to >1cm3 of brainstem or >57Gy delivered to >0.1cm3 of brainstem or >50Gy to 1% or 0.1cm3 of globes).
- •Recurrence with leptomeningeal disease or only leptomeningeal disease.
- •Recurrence defined by non-enhancing disease only.
- •More than three enhancing lesions present on MRI or multi-focal recurrence.
- •IDH1/2 mutant tumours on original pathology (to avoid unbalance between arms).
- •GBM with known features of PXA, BRAF mutations or 1p19q co-deletion (on original pathology or updated pathology if available)
- •Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of one year.
- •Severe active co-morbidity making patient unsuitable for chemotherapy or re-irradiation (e.g. uncontrolled diabetes, uncontrolled hypertension).
- •Prior allergic reaction to nitrosoureas.
- •Coeliac disease.
- •Any recognised genetic syndrome causing sensitivity to radiotherapy.
- •Patient unwilling/ unable to attend for follow up in the radiotherapy centre.
- •Contraindication to MRI or gadolinium.
- •Previous radiotherapy dose distribution unavailable.
- •Previous systemic therapy or re-irradiation for recurrent GBM.
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