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Current Trials

ANZMTG 01.07 - WBRTMel Trial

This international, randomized, phase III trial will determine if the addition of whole brain radiotherapy after surgery or local stereotactic radiotherapy improves the control of melanoma metastases in the brain, neurocognitive function, survival and quality of life.

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ANZMTG 01.07 SS01.13 - The Hair Spare Study

Whole Brain Radiotherapy (WBRT) is a common palliative treatment for brain metastases (BMs). WBRT is traditionally given with opposed lateral fields. With this technique, the hair bearing scalp skin receives the full dose, resulting in acute epilation often leading to alopecia, so decreasing quality of life (QoL). VMAT HSWBRT is the acronym for volumetric modulated arc therapy hair sparing whole brain radiotherapy. VMAT may allow hair sparing (HS) when delivering WBRT. This study will investigate whether VMAT HSWBRT can minimise acute epilation while delivering effective WBRT, thereby improving QoL.

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ANZMTG 01.09 RTN2 Trial - A Randomised Trial of Post-Operative Radiation Therapy Following Wide Excision

Neurotropism, defined as invasion by melanoma of peripheral neural tissue, is uncommon but it is this feature which is linked with a high risk of the cancer coming back in the same area. The primary aim of this trial is to determine if there is a difference in the rate of relapse between 2 randomised groups of patients treated after surgery with either radiation therapy or initial observation.

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ANZMTG 02.09 Mel-D Trial - Vitamin D following primary treatment of melanoma at high risk of recurrence

There is currently no high evidence to show that Vitamin D can improve melanoma prognosis. This is a pilot phase II study which aims to  determine whether administration of a loading oral dose of 500,000 IU of Vitamin D followed by a monthly oral dose of 50,000 IU of Vitamin D for 2 years following primary treatment of melanoma at high risk of recurrence.

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ANZMTG 01.10 - CARPETS

Oral kinase inhibitors are proving to be effective in up to 60% of malignant melanomas that are found to have a BRAF mutation. However, drug resistance is emerging and many patients relapse affirming the need for further treatment development. This Phase I study is assessing the safety and immune effects of using autologous peripheral blood T cells in GD2 positive patients being treated with vemurafenib.

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ANZMTG 01.12 EAGLE FM Trial - Inguinal or Ilio-inguinal Lymphadenectomy for patients with metastatic melanoma to groin lymph nodes and no evidence of pelvic disease on PET/CT Scan - A randomised phase III trial

Spread of metastatic melanoma to the groin lymph nodes is a common event for patients with melanoma. In melanoma treatment centres around the world, management of patients with clear pelvic lymph node disease vary. Thismulti-centre, phase III, prospective, randomised clinical trial aims to assess the effectiveness and morbidity of Complete Inguinal Lymphadenectomy versus Complete Ilio-ingional Lymphadenectomy for patients with metastatic melanoma and negative pelvic staging on PET / CT scan.

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ANZMTG 02.12 RADICAL Trial - A randomised controlled multicentre trial of imiquimod versus radiotherapy for lentigo maligna (LM) when staged surgical excision with 5mm margins is not possible, is refused, or fails

To date, there have been no prospective studies or randomised controlled trials (RCT) conducted to form the basis of any recommendations for the management of Lentigo Maligna. In order to establish the optimum management for these patients and to accurately evaluatethese treatments a prospective randomised controlled clinical trial is required.

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ANZMTG 03.12 MelMarT Trial - A Phase III, multi-centre, multi-national randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with a primary invasive cutaneous melanomas >=1mm thick to determine differences in the rate of local recurrence and melanoma specific survival. A reduction in margins is expected to improve quality of life in patients.

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ANZMTG 01.13 Trial - A randomised controlled trial of a psycho-educational intervention for melanoma survivors at high risk of developing new primary disease

There are very few psychosocial resources designed to address the information and support needs of melanoma patients. This randomised controlled clinical trials  aims to evaluate the efficacy of a psycho-educational intervention in reducing fear of melanoma recurrence (defined in this study as fear of melanoma recurrence as well as fear of developing new primary disease) in melanoma survivors at high risk of developing new primary melanoma, compared to usual care.

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ANZMTG 01.14 ABC Trial - A phase II study of nivolumab and nivolumab combined with ipilimumab in patients with melanoma brain metastases

A phase II study of nivolumab and nivolumab in combination with ipilimumab in patients with melanoma brain metastases.

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ANZMTG 02.14 CombiRT Trial - An open-label, single-arm, phase I/II, multicenter study to evaluate safety and efficacy of combination of dabrafenib, trametinib and palliative radiotherapy in metastatic BRAF mutation positive cutaneous melanoma

An open-label, single-arm, phase I/II, multicenter study to evaluate the safety and efficacy of the combination of dabrafenib, trametinib and palliative radiotherapy in patients with inoperable (stage IIIc) and metastatic (stage IV) BRAF V600E/K mutation-positive cutaneous melanoma.

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ANZMTG 01.15 CHARLI Trial

A Phase II Trial of Ipilimumab-Nivolumab-Denosumab and Nivolumab-Denosumab in Patients with Unresectable Stage III and IV Melanoma (Short Title: CHARLI (Checkpoint And RANK-L Inhibition))

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