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

Primary Purpose

Metastatic Melanoma

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WBRT
Sponsored by
Melanoma and Skin Cancer Trials Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring Whole Brain Radiotherapy, Brain metastases, Melanoma, Stage IV Metastatic Melanoma, Neurocognitive function, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St Vincent's Hospital
  • Calvary Mater Hospital
  • Genesis Cancer Care - Gateshead
  • Melanoma Institute Australia / Royal Prince Alfred Hospital
  • Nepean Hospital
  • Westmead Hospital
  • Darwin Hospital, NT Radiation Oncology
  • Royal Brisbane and Women's Hospital
  • Radiation Oncology Services - Mater Centre
  • Townsville Hospital
  • Genesis Cancer Care - Tugun
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Royal Hobart Hospital
  • Peter MacCallum Cancer Centre
  • Alfred Hospital
  • Sir Charles Gairdner Hospital
  • The Norwegian Radium Hospital
  • Velindre Hospital
  • Mount Vernon Cancer Centre
  • Churchill Hospital
  • St. James University Hospital
  • Norfolk & Norwich University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

WBRT

Observation

Arm Description

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

No Intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to intracranial failure (local, distant and overall) as determined by MRI
Quality of life as measured by EORTC QLQ-C30 and BN-20
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).
Overall survival
Performance status as measured by ECOG
Incremental cost effectiveness ratio (ICER)

Full Information

First Posted
December 15, 2011
Last Updated
January 6, 2021
Sponsor
Melanoma and Skin Cancer Trials Limited
Collaborators
Trans Tasman Radiation Oncology Group, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT01503827
Brief Title
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma
Acronym
WBRTMel
Official Title
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melanoma and Skin Cancer Trials Limited
Collaborators
Trans Tasman Radiation Oncology Group, University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Whole Brain Radiotherapy, Brain metastases, Melanoma, Stage IV Metastatic Melanoma, Neurocognitive function, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WBRT
Arm Type
Experimental
Arm Description
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
Arm Title
Observation
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Radiation
Intervention Name(s)
WBRT
Intervention Description
A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
Primary Outcome Measure Information:
Title
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment
Time Frame
12 months post randomisation
Secondary Outcome Measure Information:
Title
Time to intracranial failure (local, distant and overall) as determined by MRI
Time Frame
Post randomisation to intracranial failure
Title
Quality of life as measured by EORTC QLQ-C30 and BN-20
Time Frame
At baseline and every 2 months post randomisation
Title
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
Title
Overall survival
Time Frame
Post randomisation to death from any cause
Title
Performance status as measured by ECOG
Time Frame
At baseline and every 2 months post randomisation
Title
Incremental cost effectiveness ratio (ICER)
Time Frame
At 12 months from randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Fogarty, BSc, MBBS
Organizational Affiliation
Mater Hospital, St Vincent's Hospital, Melanoma Institue Australia
Official's Role
Study Chair
Facility Information:
Facility Name
St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Calvary Mater Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2310
Country
Australia
Facility Name
Genesis Cancer Care - Gateshead
City
Newcastle
State/Province
New South Wales
Country
Australia
Facility Name
Melanoma Institute Australia / Royal Prince Alfred Hospital
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Nepean Hospital
City
Penrith
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Darwin Hospital, NT Radiation Oncology
City
Darwin
State/Province
Northern Territory
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Radiation Oncology Services - Mater Centre
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Townsville Hospital
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4812
Country
Australia
Facility Name
Genesis Cancer Care - Tugun
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
The Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Velindre Hospital
City
Whitchurch
State/Province
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Churchill Hospital
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
St. James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Norfolk & Norwich University Hospital
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21496312
Citation
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.
Results Reference
background
PubMed Identifier
31553661
Citation
Hong AM, Fogarty GB, Dolven-Jacobsen K, Burmeister BH, Lo SN, Haydu LE, Vardy JL, Nowak AK, Dhillon HM, Ahmed T, Shivalingam B, Long GV, Menzies AM, Hruby G, Drummond KJ, Mandel C, Middleton MR, Reisse CH, Paton EJ, Steel V, Williams NC, Scolyer RA, Morton RL, Thompson JF. Adjuvant Whole-Brain Radiation Therapy Compared With Observation After Local Treatment of Melanoma Brain Metastases: A Multicenter, Randomized Phase III Trial. J Clin Oncol. 2019 Nov 20;37(33):3132-3141. doi: 10.1200/JCO.19.01414. Epub 2019 Sep 25.
Results Reference
derived
PubMed Identifier
31382986
Citation
Lo SN, Hong AM, Haydu LE, Ahmed T, Paton EJ, Steel V, Hruby G, Tran A, Morton RL, Nowak AK, Vardy JL, Drummond KJ, Dhillon HM, Mandel C, Scolyer RA, Middleton MR, Burmeister BH, Thompson JF, Fogarty GB. Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan. Trials. 2019 Aug 5;20(1):477. doi: 10.1186/s13063-019-3555-5.
Results Reference
derived

Learn more about this trial

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

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