Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

NCT ID: NCT01503827

Last Updated: 2021-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

WBRT

Intervention Type: RADIATION

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

Observation

No Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

WBRT

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

Melanoma and Skin Cancer Trials Limited

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald Fogarty, BSc, MBBS

Role: STUDY_CHAIR

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

Locations

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Calvary Mater Hospital

Newcastle, New South Wales, Australia

Genesis Cancer Care - Gateshead

Newcastle, New South Wales, Australia

Melanoma Institute Australia / Royal Prince Alfred Hospital

North Sydney, New South Wales, Australia

Nepean Hospital

Penrith, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Darwin Hospital, NT Radiation Oncology

Darwin, Northern Territory, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Radiation Oncology Services - Mater Centre

South Brisbane, Queensland, Australia

Townsville Hospital

Townsville, Queensland, Australia

Genesis Cancer Care - Tugun

Tugun, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

The Norwegian Radium Hospital

Oslo, , Norway

Velindre Hospital

Whitchurch, Cardiff, United Kingdom

Mount Vernon Cancer Centre

Northwood, Middlesex, United Kingdom

Churchill Hospital

Headington, Oxford, United Kingdom

St. James University Hospital

Leeds, , United Kingdom

Norfolk & Norwich University Hospital

Norwich, , United Kingdom

Countries

Australia; Norway; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 21496312 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37441544 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31553661 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31382986 (View on PubMed)

Related Links

http://anzmtg.org/trialdetails.aspx?trialno=5

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

Other Identifiers

ACTRN12607000512426

Identifier Type: REGISTRY

Identifier Source: secondary_id

01-07

Identifier Type: -

Identifier Source: org_study_id