ISRCTN16052954进行中（未招募）2 期
Brain Re-Irradiation Or Chemotherapy: a Phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma
niversity of Leeds0 个研究点目标入组 70 人开始时间: 2021年2月25日最近更新:
适应症
试验速览
- 阶段
- 2 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
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38458809/ (added 11/03/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histologically proven diagnosis of GBM with consistent molecular pathology, based on original pathology (repeat biopsy at recurrence is NOT required).
- •2. 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).
- •3. 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 pseudoprogression.
- •4. 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 4.1 Inclusion Criteria for further details for achieving this.
- •5. =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).
- •6. Prior history of standard dose, conventionally fractionated CNS radiotherapy (i.e. 54-60Gy in 28-33 fractions).
- •7. As a minimum patients will have completed at least two weeks of temozolomide, concurrent with their original radiotherapy.
- •8. Up to and including three enhancing lesions:
- •8.1. In cases of a single recurrent enhancing lesion:
- •8.1.1. 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
- •8.1.1. 1 x ½ x diameter 2 x ½ x diameter 3: see Appendix D – Calculation of volume and explanation for volume limitations for study eligibility for explanation) and
- •8.1.2. Maximum diameter of enhancing disease must be =6 cm. 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 =6 cm.
- •8.2. In cases of multiple (i.e. two or three) discrete recurrent enhancing lesions:
- •8.2.1. The total (i.e. combined) predicted reirradiation 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
- •8.2.2. Maximum diameter of the combined enhancing disease, across all enhancing lesions (including any gaps between), must be =6 cm
- •9. Karnofsky Performance Status 70+
- •10. 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 =10 g/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. See section 9.1 Chemotherapy Arm for further details). Lymphopaenia is not a contra-indication to trial entry.
- •11. 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 reirradiation for recurrence has been given. As above, this MRI must be reviewed within the local multi-disciplinary meeting,
排除标准
- •1. Pregnant (positive pregnancy test) or lactating
- •2. Critical normal brain structures treated above usual tolerance during initial radiotherapy (i.e. based on 30 fractions initial treatment, >55 Gy delivered to 1% or 0.1 cm³ of optic nerve or chiasm or >55 Gy delivered to >1 cm³ of brainstem or >57 Gy delivered to >0.1 cm³ of brainstem or >50 Gy to 1% or 0.1 cm³ of globes)
- •3. Recurrence with leptomeningeal disease or only leptomeningeal disease
- •4. Recurrence defined by non-enhancing disease only
- •5. More than three enhancing lesions present on MRI or multi-focal recurrence
- •6. IDH1/2 mutant tumours on original pathology (to avoid unbalance between arms)
- •7. GBM with known features of PXA, BRAF mutations or 1p19q co-deletion (on original pathology or updated pathology if available)
- •8. Prior invasive malignancy (except non-melanomatous skin cancer), unless disease-free for a minimum of 1 year
- •9. Severe active co-morbidity making patient unsuitable for chemotherapy or re-irradiation (e.g. uncontrolled diabetes, uncontrolled hypertension)
- •10. Prior allergic reaction to nitrosoureas
- •11. Coeliac disease
- •12. Any recognised genetic syndrome causing sensitivity to radiotherapy
- •13. Patient unwilling/unable to attend for follow up in the radiotherapy centre
- •14. Contraindication to MRI or gadolinium
- •15. Previous radiotherapy dose distribution unavailable
- •16. Previous systemic therapy or re-irradiation for recurrent GBM
研究者
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