Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma (WBRTMel)

Melanoma and Skin Cancer Trials Limited

Status

Unknown

Conditions

Metastatic Melanoma

Treatments

Radiation: WBRT

Study type

Interventional

Funder types

Other

Identifiers

NCT01503827

ACTRN12607000512426 (Registry Identifier)

01-07

Details and patient eligibility

About

People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 220 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation.
Life expectancy of at least 6 months
Aged 18 years or older
WBRT must begin within 8 weeks of completion of localised treatment and within 4 weeks of randomisation
Able to have an MRI brain scan with contrast. Estimated Glomerular Filtrate Rate (eGFR) is adequate at the discretion of the radiologist and capable of having gadolinium-containing contrast medium for MRI as per practice guidelines
Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation
An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation
CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation
Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal
Able to provide written informed consent

Exclusion criteria

Any untreated intracranial disease
Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
Evidence of leptomeningeal disease on pre-local treatment MRI scan
Patients with prior cancers, except:
- Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
- Successfully treated basal cell and squamous cell skin carcinoma;
- Carcinoma in-situ of the cervix
A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial