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Closed (no longer recruiting)Last updated: 21 December 2023

TROG 08.05: This phase III trial is assessing whole brain radiotherapy following local treatment for people with melanoma spread to the brainWhole brain radiotherapy following local treatment of intracranial metastases of melanoma. A randomised phase III trial (Other IDs: ANZMTG 1-07).

Clinical summary

Summary

People in Australia with brain metastases from melanoma are currently offered whole brain radiotherapy (WBRT) after brain surgery depending on which hospital they attend. This trial seeks to determine if WBRT reduces the spread of melanoma in the brain, and lengthens the time to melanoma returning. This trial will also examine the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised to either whole brain radiotherapy or observation following their surgery. 200 people will be recruited from melanoma centres in Australia, New Zealand and other international sites.

Conditions

This trial is treating patients with Melanoma.

Cancer

Skin Cancers Skin

Age

People18 - 75

Phase

III

Trial Acronym

TROG 08.05

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Australia and New Zealand Melanoma Trials Group (ANZMTG)

Scientific Title

Whole brain radiotherapy following local treatment of intracranial metastases of melanoma. A randomised phase III trial (Other IDs: ANZMTG 1-07).

Eligibility

Inclusion

 

1. 1-3 intracranial metastases on MRI from melanoma, locally treated with either surgical excision and/or stereotactic irradiation. 2. Life expectancy of at least 6 months 3. Aged 18 years or older 4. WBRT must be within 8 weeks of completion of localised treatment and within 4 weeks of randomisation 5. 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 6. Complete localised treatment of all these metastases no more than 6 weeks prior to randomisation 7. An Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less at randomisation 8. CT scan of chest, abdomen and pelvis as a minimum prior to randomisation. Scans must be within 12 weeks of randomisation 9. Serum Lactate Dehydrogenase (LDH) must be = or < 2 x upper limit of normal 10. Able to provide written informed consent

Exclusion

1. Any untreated intracranial disease
2. Any previous intracranial treatment (surgical excision and/or stereotactic irradiation treatment and/or WBRT) prior to this diagnosis of intracranial melanoma
3. Evidence of leptomeningeal disease on pre-local treatment MRI scan
4. Patients with prior cancers, except:
o Those diagnosed more than five years ago with no evidence of disease recurrence within this time;
o Successfully treated basal cell and squamous cell skin carcinoma;
o Carcinoma in-situ of the cervix
5. A medical or psychiatric condition that compromises ability to give informed consent or complete the protocol
6. Positive urine pregnancy test for women of childbearing potential within a week of registration onto the trial

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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