Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma

Conditions

Metastatic Melanoma

Keywords

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

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.

Iris Bartula, Anh Tran, Anna K. Nowak, Tasnia Ahmed, Rachael L. Morton et al. (12 authors)

Clinical and Translational Radiation Oncology2023-02-152 citations

10.1016/j.ctro.2023.100597

Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan.

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.

2019-08-055 citations

10.1186/s13063-019-3555-5

Phase 3 international trial of adjuvant whole brain radiotherapy (WBRT) or observation (Obs) following local treatment of 1-3 melanoma brain metastases (MBMs).

Gerald B. Fogarty, Kari Dolven-Jacobsen, Rachael L. Morton, George Hruby, Anna K. Nowak et al. (20 authors)

Journal of Clinical Oncology2019-05-206 citations

10.1200/jco.2019.37.15_suppl.9500

Quality assurance analysis of hippocampal avoidance in a melanoma whole brain radiotherapy randomized trial shows good compliance.

Martinage G, Hong AM, Fay M, Thachil T, Roos D, Williams N, Lo S, Fogarty G.

2018-07-205 citations

10.1186/s13014-018-1077-z

Interventions

RADIATIONWBRT

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients with distant intracranial failure as determined by magnetic resonance imaging (MRI) assessment	12 months post randomisation

Secondary

Measure	Time frame
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
Time to intracranial failure (local, distant and overall) as determined by MRI	Post randomisation to intracranial failure
Performance status as measured by ECOG	At baseline and every 2 months post randomisation
Incremental cost effectiveness ratio (ICER)	At 12 months from randomisation
Overall survival	Post randomisation to death from any cause

Countries

Australia, Norway, United Kingdom

Outcome results

None listed