WBRTMel: Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

• Sponsor: Melanoma and Skin Cancer Trials Limited (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01503827
• Collaborator: Trans Tasman Radiation Oncology Group (Other), University of Oxford (Other)
• Enrollment: 220
• Locations: 23
• Arms: 2
• Duration (Months): 176
• Patients Per Site: 9.6
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Radiation: WBRT	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2017
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Radiation: WBRT; A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
No Intervention: Observation No Intervention

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment [12 months post randomisation]

Secondary Outcome Measures

1. Time to intracranial failure (local, distant and overall) as determined by MRI [Post randomisation to intracranial failure]

2. Quality of life as measured by EORTC QLQ-C30 and BN-20 [At baseline and every 2 months post randomisation]

3. 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). [At baseline and every 2 months post randomisation]

4. Overall survival [Post randomisation to death from any cause]

5. Performance status as measured by ECOG [At baseline and every 2 months post randomisation]

6. Incremental cost effectiveness ratio (ICER) [At 12 months from randomisation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Vincent's Hospital	Darlinghurst	New South Wales	Australia	2010
2	Calvary Mater Hospital	Newcastle	New South Wales	Australia	2310
3	Genesis Cancer Care - Gateshead	Newcastle	New South Wales	Australia
4	Melanoma Institute Australia / Royal Prince Alfred Hospital	North Sydney	New South Wales	Australia	2060
5	Nepean Hospital	Penrith	New South Wales	Australia	2751
6	Westmead Hospital	Westmead	New South Wales	Australia
7	Darwin Hospital, NT Radiation Oncology	Darwin	Northern Territory	Australia
8	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4029
9	Radiation Oncology Services - Mater Centre	South Brisbane	Queensland	Australia	4101
10	Townsville Hospital	Townsville	Queensland	Australia	4812
11	Genesis Cancer Care - Tugun	Tugun	Queensland	Australia	4224
12	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
13	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
14	Royal Hobart Hospital	Hobart	Tasmania	Australia	7000
15	Peter MacCallum Cancer Centre	East Melbourne	Victoria	Australia	8006
16	Alfred Hospital	Melbourne	Victoria	Australia	3004
17	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
18	The Norwegian Radium Hospital	Oslo		Norway	0310
19	Velindre Hospital	Whitchurch	Cardiff	United Kingdom	CF14 2TL
20	Mount Vernon Cancer Centre	Northwood	Middlesex	United Kingdom	HA6 2RN
21	Churchill Hospital	Headington	Oxford	United Kingdom	OX3 7LJ
22	St. James University Hospital	Leeds		United Kingdom	LS9 7TF
23	Norfolk & Norwich University Hospital	Norwich		United Kingdom	NR4 7UY

Sponsors and Collaborators

• Melanoma and Skin Cancer Trials Limited
• Trans Tasman Radiation Oncology Group
• University of Oxford

Investigators

• Study Chair: Gerald Fogarty, BSc, MBBS, Mater Hospital, St Vincent's Hospital, Melanoma Institue Australia

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Melanoma and Skin Cancer Trials Limited
• ClinicalTrials.gov Identifier: NCT01503827
• Other Study ID Numbers: 01-07; ACTRN12607000512426
• First Posted: Jan 4, 2012
• Last Update Posted: Jan 7, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Melanoma and Skin Cancer Trials Limited: Whole Brain Radiotherapy; Brain metastases; Melanoma; Stage IV Metastatic Melanoma; Neurocognitive function; Quality of life
• Additional relevant MeSH terms: Melanoma; Neoplasm Metastasis

Study Results

No Results Posted as of Jan 7, 2021