ISRCTN12545499已完成3 期
Whole Brain Radiotherapy following local treatment of intracranial metastases of melanoma a randomised phase III trial
niversity of Oxford (UK)0 个研究点目标入组 200 人开始时间: 2011年7月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
2015 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/25952979 interim analysis (added 04/09/2019) 2011 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/21496312 protocol (added 04/09/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31553661/ (added 07/11/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 10/04/2014:
- •1. One to three intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. It will be assumed that the metastases are melanoma if the patient has documented histological or radiological concurrent extracranial disease that has already made the patient stage IV. If the cerebral lesion(s) is/are the first presentation of stage IV disease, then one metastasis must be histologically proven to be melanoma for the patient to be included in the study
- •2. Life expectancy of at least 6 months
- •3. Aged 18 years or older
- •4. WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
- •5. Able to have an MRI brain scan with contrast. Estimated Glomerular Filtration Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI (as per practice guidelines).
- •6. Localised treatment of all these metastases no more than 6 weeks prior to randomisation
- •7. An ECOG performance status between 0 and 2 at randomisation
- •8. CT or PET scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
- •9. Serum Lactate Dehydrogenase (LDH) must be = 2 x upper limit of normal
- •10. Able to provide written informed consent
- •11. Male or female participants
- •Previous inclusion criteria:
- •1. One to three intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. It will be assumed that the metastases are melanoma if the patient has documented histological or radiological concurrent extracranial disease that has already made the patient stage IV. If the cerebral lesion(s) is/are the first presentation of stage IV disease, then one metastasis must be histologically proven to be melanoma for the patient to be included in the study
- •2. Life expectancy of at least 6 months
- •3. Aged 18 years or older
- •4. WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
- •5. Able to have an MRI brain scan with contrast. Estimated Glomerular Filtration Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI (as per practice guidelines).
- •6. Localised treatment of all these metastases no more than 6 weeks prior to randomisation
- •7. An ECOG performance status between 0 and 2 at randomisation
- •8. CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
- •9. Serum Lactate Dehydrogenase (LDH) must be = 2 x upper limit of normal
- •10. Able to provide written informed consent
- •11. Male or female participants
排除标准
- •1. Any untreated intracranial disease
- •2. Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
- •3. Evidence of leptomeningeal disease on pre-local treatment MRI scan
- •4. Patients with prior cancers, except:
- •4.1. Those diagnosed more than five years ago with no evidence of disease recurrence within this time
- •4.2. Successfully treated basal cell and squamous cell skin carcinoma
- •4.3. Carcinoma in-situ of the cervix
- •5. A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
- •6. Positive urine pregnancy test for women of childbearing potential (+/-7 days of registration onto the trial)
研究者
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