Whole Brain Radiotherapy following local treatment of melanoma

Phase 3

Completed

• Conditions: Melanoma; Cancer

• Registration Number: ISRCTN12545499
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-28
• Study Completion: 2018-04-30
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified