Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

NCT01503827 | Unknown DMC

• 2 other identifiers: 01-07ACTRN12607000512426
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 23

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.

Conditions

Metastatic Melanoma

Keywords

Whole Brain Radiotherapy; Brain metastases; Melanoma; Stage IV Metastatic Melanoma; Neurocognitive function; Quality of life

Outcome Measures

Primary Outcomes (1)

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

  12 months post randomisation

Secondary Outcomes (6)

• Time to intracranial failure (local, distant and overall) as determined by MRI

  Post randomisation to intracranial failure

• Quality of life as measured by EORTC QLQ-C30 and BN-20

  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).

  At baseline and every 2 months post randomisation

• Overall survival

  Post randomisation to death from any cause

• Performance status as measured by ECOG

  At baseline and every 2 months post randomisation

Study Arms (2)

WBRT

EXPERIMENTAL

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

Observation

NO INTERVENTION

No Intervention

Interventions

WBRT RADIATION

A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation

WBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (23)

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Calvary Mater Hospital

Newcastle, New South Wales, 2310, Australia

Location

Genesis Cancer Care - Gateshead

Newcastle, New South Wales, Australia

Location

Melanoma Institute Australia / Royal Prince Alfred Hospital

North Sydney, New South Wales, 2060, Australia

Location

Nepean Hospital

Penrith, New South Wales, 2751, Australia

Location

Westmead Hospital

Westmead, New South Wales, Australia

Location

Darwin Hospital, NT Radiation Oncology

Darwin, Northern Territory, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Radiation Oncology Services - Mater Centre

South Brisbane, Queensland, 4101, Australia

Location

Townsville Hospital

Townsville, Queensland, 4812, Australia

Location

Genesis Cancer Care - Tugun

Tugun, Queensland, 4224, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 8006, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

The Norwegian Radium Hospital

Oslo, 0310, Norway

Location

Velindre Hospital

Whitchurch, Cardiff, CF14 2TL, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

Churchill Hospital

Headington, Oxford, OX3 7LJ, United Kingdom

Location

St. James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Norfolk & Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 21496312 BACKGROUND

• Bartula I, Tran AD, Nowak AK, Ahmed T, Morton RL, Burmeister BH, Dolven-Jacobsen K, Nobes J, Thompson JF, Fogarty GB, Lo SN, Hong AM. Longitudinal trajectory of quality of life for patients with melanoma brain metastases: A secondary analysis from a whole brain radiotherapy randomized clinical trial. Clin Transl Radiat Oncol. 2023 Feb 15;41:100597. doi: 10.1016/j.ctro.2023.100597. eCollection 2023 Jul.

  PMID: 37441544 DERIVED

• 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.

  PMID: 31553661 DERIVED

• 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.

  PMID: 31382986 DERIVED

Related Links

• Click here for more information about this study: Whole Brain Radiotherapy following local treatment of intracranial metastases of melanoma

MeSH Terms

Conditions

Melanoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gerald Fogarty, BSc, MBBS

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: January 4, 2012
• Study Start: October 1, 2007
• Primary Completion: September 1, 2017
• Study Completion: June 1, 2022
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (17); NO (1); GB (5)