Know Cancer

forgot password

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial

Phase 3
18 Years
Open (Enrolling)
Metastatic Melanoma

Thank you

Trial Information

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial

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

- An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment

Outcome Time Frame:

12 months post randomisation

Safety Issue:


Principal Investigator

Gerald Fogarty, BSc, MBBS

Investigator Role:

Study Chair

Investigator Affiliation:

Mater Hospital, St Vincent's Hospital, Melanoma Institue Australia


Australia: Human Research Ethics Committee

Study ID:

ANZMTG 01-07



Start Date:

October 2007

Completion Date:

June 2016

Related Keywords:

  • Metastatic Melanoma
  • Whole Brain Radiotherapy
  • Brain metastases
  • Melanoma
  • Stage IV Metastatic Melanoma
  • Neurocognitive function
  • Quality of life
  • Melanoma
  • Neoplasm Metastasis



Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033