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

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ClinicalTrials.gov Identifier: NCT01503827
Recruitment Status : Active, not recruiting
First Posted : January 4, 2012
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
Trans-Tasman Radiation Oncology Group (TROG)
University of Oxford
Information provided by (Responsible Party):
Australia and New Zealand Melanoma Trials Group

December 15, 2011
January 4, 2012
March 9, 2018
October 2007
September 2017   (Final data collection date for primary outcome measure)
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment [ Time Frame: 12 months post randomisation ]
Same as current
Complete list of historical versions of study NCT01503827 on ClinicalTrials.gov Archive Site
  • Time to intracranial failure (local, distant and overall) as determined by MRI [ Time Frame: Post randomisation to intracranial failure ]
  • Quality of life as measured by EORTC QLQ-C30 and BN-20 [ Time Frame: At baseline and every 2 months post randomisation ]
  • Neurocognitive function as measured by Hopkins Verbal Learning Test, Controlled Oral Word Association Test, Trail Making Test Part A & B, Stroop - Colour and Word Test and Digit Span (Forwards and Backwards). [ Time Frame: At baseline and every 2 months post randomisation ]
  • Overall survival [ Time Frame: Post randomisation to death from any cause ]
  • Performance status as measured by ECOG [ Time Frame: At baseline and every 2 months post randomisation ]
  • Incremental cost effectiveness ratio (ICER) [ Time Frame: At 12 months from randomisation ]
  • Time to intracranial failure (local, distant and overall) as determined by MRI [ Time Frame: 12 and 24 months post randomisation ]
  • Quality of life as measured by QLQ-C30 and BN-20 [ Time Frame: At baseline and every 2 months post randomistion for 2 years ]
  • Neurocognitive function as measured by Hopkins verbal Learning Test, Controlled Oral Word Association Test, Trail Making Test Part A & B [ Time Frame: At baseline and every 2 months post randomisation for 2 years ]
  • Overall survival [ Time Frame: post randomisation to intracranial failure or death from any cause, whichever came first, assessed up to 24 months ]
Not Provided
Not Provided
 
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Melanoma
Radiation: WBRT
A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
  • Experimental: WBRT
    Patients will receive WBRT after local treatment. A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
    Intervention: Radiation: WBRT
  • No Intervention: Observation
    No Intervention
Fogarty G, Morton RL, Vardy J, Nowak AK, Mandel C, Forder PM, Hong A, Hruby G, Burmeister B, Shivalingam B, Dhillon H, Thompson JF. Whole brain radiotherapy after local treatment of brain metastases in melanoma patients--a randomised phase III trial. BMC Cancer. 2011 Apr 17;11:142. doi: 10.1186/1471-2407-11-142.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
200
June 2022
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Norway,   United Kingdom
United States
 
NCT01503827
ANZMTG 01-07
ACTRN12607000512426 ( Registry Identifier: ANZCTR )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Australia and New Zealand Melanoma Trials Group
Australia and New Zealand Melanoma Trials Group
  • Trans-Tasman Radiation Oncology Group (TROG)
  • University of Oxford
Study Chair: Gerald Fogarty, BSc, MBBS Mater Hospital, St Vincent's Hospital, Melanoma Institue Australia
Australia and New Zealand Melanoma Trials Group
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP