Completed and Published Trials

The clinical trials listed below have ended. The results of these trials have been published in medical journals, or manuscript preparation is underway.

Click on the links below for further information about these completed and published trials.

MASC Trials cannot enrol patients into a trial. Learn how to participate in one of our clinical trials here.

Metastatic Melanoma

Cutaneous Melanoma

Melanoma

01.02 Adj RT
01.07 SS 01.13 Hair Spare
02.14 CombiRT
06.17 iMOVE
04.18 Surgical Management Survey

01.06 MSLT-I
02.06 MSLT-II
02.09 Mel-D

01.09 MelQOL Research Study
01.13 Psycho-educational intervention
02.17 MEL-SELF (pilot)
03.17 Skin Cancer Prevention

Skin cancer

04.17 SMARTI

A Pilot Study of an Artificial Intelligence System as a Diagnostic Aide for Better Skin Cancer Management

Chair

Associate Professor Victoria Mar

Registration ID

NCT04040114

Trial Status

Completed and Published Trial

Trial Summary

MoleMap is a recently developed artificial intelligence algorithm that uses digital photography to capture images of the entire body to determine malignant lesions. It has the potential to help primary care doctors in making more appropriate referrals to specialists for patients with suspicious lesions.

The SMARTI study investigated the accuracy of Molemap Artificial Intelligence (AI) compared to dermatologists’ clinical judgement in diagnosing skin cancers. This pilot study involved 214 participants across Victoria.

Trial Findings

Digital photography combined with the newly developed MoleMap AI algorithm was shown to have substantial agreement with a treating dermatologist’s face-to-face assessment of whether a lesion was benign or malignant, and accuracy that compares favourably to that of a dermatologist’s remote (telehealth) assessment.

The trial’s results give the researchers confidence to further examine this AI tool in a larger cohort across more Australian sites and in the General Practice setting.

Main publications

Journal of the American Academy of Dermatology
BMJ Open – Dermatology

MASC Trials Contact

smarti@masc.org.au

01.02 Adj RT

A randomised clinical trial of surgery versus surgery plus adjuvant radiotherapy of regional control in patients with completely resected nodal metastatic melanoma

Chair

Professor Michael Henderson and Professor Bryan Burmeister

Registration ID

ACTRN1260700003415

Trial Status

Completed and Published Trial

Trial Summary

In its advanced stages, melanoma can spread to the lymph nodes of the body. These affected lymph nodes can be removed through a surgical lymphadenectomy. The efficacy of radiotherapy after surgery is controversial among clinicians.

The Adj RT trial investigated whether adding post-operative radiotherapy is more effective in preventing return of the cancer in high-risk patients.

This international, randomised phase III trial involved 16 sites across Australia, The Netherlands, New Zealand and Brazil, with a total of 250 participants.

Trial Findings

The study found that post-operative radiotherapy helped reduce recurrence of melanoma in high-risk participants with completely resected nodal metastatic melanoma. These findings will aid clinicians in deciding whether to use post-operative radiotherapy and help raise discussions with their patients regarding this option.

Main publication

https://www.ncbi.nlm.nih.gov/pubmed/22575589

MASC Trials Contact

hello@masc.org.au

01.06 MSLT-I

Multicentre selective lymphadenectomy trial - I

Chair

Professor John Thompson

Registration ID

NCT00275496

Trial Status

Completed and Published Trial

Trial Summary

To treat skin melanoma, surgical removal of the lesion is performed. As part of previous protocol, patients were monitored post-operatively for cancer spread to nearby lymph nodes. Only when there was evidence of spread, did patients undergo surgical removal of affected lymph nodes (lymphadenectomy).

Sentinel lymph node biopsy is a technique used in melanoma surgery and involves mapping and evaluating nearby lymph nodes for melanoma spread intra-operatively. Removal of these nodes is then performed immediately if there is evidence of spread.

The MSLT-I trial investigated if excision with sentinel node biopsy improved patient survival compared to the usual care of excision and observation. Furthermore, the efficacy of performing lymphadenectomy immediately after excision, regardless of evidence of nodal spread, was evaluated.

Trial Findings

The study’s findings corroborate the use of sentinel node biopsy for patients with higher risk melanomas, as it provided valuable prognostic information and improved patient survival.

Main publication

https://www.nejm.org/doi/full/10.1056/nejmoa1310460

MASC Trials Contact

hello@masc.org.au

02.06 MSLT-II

Multicentre selective lymphadenectomy trial - II

Chair

Professor John Thompson

Registration ID

NCT00297895

Trial Status

Completed and Published Trial

Trial Summary

As concluded from the MSLT-I trial, there is value in the use of sentinel lymph node biopsy (SLNB) in providing prognostic and staging information to melanoma patients.

The MSLT-II trial investigated if performing removal of all local lymph nodes was more efficacious than close surveillance in patients showing evidence of nodal cancer spread via SLNB.

This was an international multi-centre trial, with 1,939 participants from countries including Australia, USA, Finland and Italy.

Trial Findings

The trial found that performing complete lymph node removal improved disease control in patients but did not improve melanoma-related survival compared to SLNB with monitoring alone.

Main publication

https://www.nejm.org/doi/full/10.1056/NEJMoa1613210

MASC Trials Contact

hello@masc.org.au

01.07 SS 01.13 Hair Spare

A feasibility study of hair sparing whole brain radiotherapy with volumetric modulated arc therapy for patients who have brain metastases from any malignancy

Chair

Professor Gerald Fogarty

Registration ID

ACTRN12617000507381

Trial Status

Completed and Published Trial

Trial Summary

To treat cancer that has spread to the brain, standard whole-brain radiotherapy (WBRT) is often used. However, this comes with unfavourable side effects such as hair loss. A new form of WBRT, volumetric modulated arc therapy WBRT (VMAT WBRT), is proposed to reduce the associated hair loss whilst still delivering effective treatment.

The SS Hair Spare trial aimed to determine if VMAT WBRT reduced radiotherapy-associated hair loss compared to standard WBRT, without compromising disease control of the cancer.

Trial Findings

The study found that the use of VMAT WBRT yielded a partial reduction in hair loss compared to standard WBRT, four weeks after radiotherapy administration, while still providing disease control.

Main publication

https://medcraveonline.com/IJRRT/IJRRT-07-00274.pdf

MASC Trials Contact

hello@masc.org.au

01.09 MelQOL Research Study

Improving Quality of Life (QOL) measurement for melanoma patients and their families: Validity and reliability study of QOL instruments in an Australian sample

Chair

Julie Winstanley

Registration ID

ACTRN12609000344291

Trial Status

Completed and Published Trial

Trial Summary

Melanoma can have devastating effects on the patient and their loved ones, both physically and psychologically. Therefore, it is important to develop new questionnaire tools to identify issues relating to quality of life (QoL) for the patient and their family.

A current tool to measure QoL is the European Organisation for Research and Treatment of Cancer (EORTC QoL) tool. However, this instrument is not cancer specific.

The MelQOL Research Study tested the reliability of this tool in authentically capturing QoL issues specifically for melanoma patients.

Trial Findings

Using the study’s results, the research team created a provisional melanoma-specific QoL tool, EORTC QLQ-MEL38. This tool has the potential to be used globally in clinical settings, and is aiding clinicians to deliver the best care for melanoma patients to optimise QoL.

Main publication

https://pubmed.ncbi.nlm.nih.gov/25325247/

MASC Trials Contact

hello@masc.org.au

02.09 Mel-D

Vitamin D following primary treatment of melanoma at high risk of recurrence - a pilot placebo controlled randomised Phase II trial

Chair

Associate Professor Robyn Saw

Registration ID

ACTRN12609000351213

Trial Status

Completed

Trial Summary

Despite surgical removal of the lesion, melanoma may return in a patient. Currently, there are no effective, non-toxic therapies used post-operatively to prevent the recurrence of melanoma. There has been evidence from past research that vitamin D may have anti-melanoma activity.

To test this idea, the Mel-D trial investigated if administering high-dose vitamin D therapy for post-operative melanoma patients helped reduce the chance of melanoma returning.

This is a phase II randomised control trial, involving 75 participants in Australia.

Main publication

In preparation

MASC Trials Contact

hello@masc.org.au

01.13 Psycho-educational intervention

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

Chair

Associate Professor Anne Cust and Dr Mbathio Dieng

Registration ID

ACTRN12613000304730

Trial Status

Completed and Published Trial

Trial Summary

After successful treatment, many melanoma patients still fear their melanoma returning. Despite this common fear, psychological support is not routinely offered as part of their ongoing care.

The Psycho-educational Intervention trial set out to determine the efficacy of a psycho-educational intervention in reducing the fear of cancer recurrence for high-risk patients with previous melanoma.

Trial Findings

Through this trial, it was found that psycho-educational intervention was effective in reducing fear and stress amongst patients and improved their understanding of melanoma. This has important implications for patient care and indicates the significance of ongoing psychological support after cancer treatment.

Main publication

http://ascopubs.org/doi/full/10.1200/JCO.2016.68.2278

MASC Trials Contact

hello@masc.org.au

02.14 CombiRT

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

Chair

Dr Tim Wang

Registration ID

ACTRN12615000292572

Trial Status

Completed and Published Trial

Trial Summary

In many cases, advanced melanoma cannot be treated with surgical removal alone, thus other options need to be explored. Standard management in these instances includes combination targeted therapy, such as Dabrafenib and Trametinib.

To improve the symptoms associated with advanced melanoma, radiotherapy shows potential to be effective. However, radiotherapy can have associated toxicities and unpleasant side effects for the patient. To investigate this, the CombiRT trial assessed the safety and effectiveness of adding radiotherapy to combination targeted therapy in patients with advanced, unresectable melanoma.

Trial Findings

The study concluded that Dabrafenib and Trametinib may be safely used concurrently with common palliative radiotherapy doses in advanced melanoma patients. This has significant implications in improving quality of life for melanoma patients undergoing targeted therapy.

Main publication

https://www.sciencedirect.com/science/article/pii/S2405630821000744

MASC Trials Contact

hello@masc.org.au

02.17 MEL-SELF (pilot)

Pilot trial: Can patient-led surveillance detect more early stage recurrent or new primary melanoma than clinician-led surveillance?

Chair

Dr Katy Bell

Registration ID

ACTRN12616001716459

Trial Status

Completed

Trial Summary

After treatment of early-stage melanoma, it is important for patients to continue regular surveillance of their skin for the presence of new cancerous lesions. Current standard care involves regular clinic visits and clinician-led monitoring; however, this practice is resource-intensive and has not shown to improve health outcomes.

Patient-led surveillance involves patients conducting their own skin-checks, with the aid of digital apps for guidance. This approach has been proposed to improve the timely detection of melanoma recurrence.

The MEL-SELF trial aimed to compare the efficacy of patient-led surveillance against clinician-led surveillance in the earlier detection of melanoma recurrence.

Main publication

In progress

MASC Trials Contact

hello@masc.org.au

03.17 Skin Cancer Prevention

Improving skin cancer prevention: Motivating preventative behaviours using knowledge of personalised genomic risk of melanoma

Chair

Associate Professor Anne Cust

Registration ID

ACTRN12617000691347

Trial Status

Completed and Published Trial

Trial Summary

Australia has the highest overall rates of melanoma globally, with melanoma being the most common cancer in Australians aged 20-39 years old. Therefore, it is essential for Australians to engage in sun-protection measures to reduce their risk of skin cancer.

To investigate ways to improve health-seeking behaviour, the Skin Cancer Prevention study assessed whether providing personalised information to Australians regarding their genetic melanoma risk would reduce health-risk taking behaviour.

Trial Findings

This study concluded that younger Australians were more likely to engage in health-risk taking behaviour, and that providing genomic risk information is potentially beneficial in reducing these risk behaviours such as sun-exposure.

Main publication

https://www.sciencedirect.com/science/article/abs/pii/S1877782119300360?via%3Dihub

MASC Trials Contact

hello@masc.org.au

06.17 iMOVE

A personalised, semi-supervised exercise intervention to reduce fatigue for patients receiving immunotherapy for stage IV melanoma – a pilot study

Chair

Dr Donna Milne

Registration ID

ACTRN12619000952145

Trial Status

Completed and Published Trial

Trial Summary

Fatigue is a common and complex experience amongst cancer patients, often occurring as a by-product of treatment side-effects and the disease itself. It is known that exercise programs are beneficial for cancer patients in reducing fatigue, however, patients often find these programs difficult to follow.

The iMove exercise program was a 12-week personalised aerobics and resistance exercise program, involving personal guidance by an exercise physiologist. The iMOVE study evaluated the safety of the iMove program for melanoma patients and investigated barriers to participation in these programs for patients on immunotherapy. This study will have important implications for healthcare workers in identifying and addressing barriers to exercise for patients.

Trial Findings

Physical and emotional benefits of exercise were described by participants, the most predominant being fatigue reduction. Identification of preferred exercise activities and barriers will assist in developing tailored exercise program for patients receiving immunotherapy.

Main publication

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6685109/

MASC Trials Contact

hello@masc.org.au

04.18 Surgical Management Survey

Current practice for the management of patients with stage III melanoma: an international survey

Chair

Dr David Gyorki

Registration ID

N/A

Trial Status

Completed and Published Trial

Trial Summary

As per previous protocol for melanoma, completion lymph node dissection (CLND) was commonly performed in patients showing positive findings on sentinel lymph node biopsy (SLNB). This involves removing local lymph nodes at the time of biopsy, and is associated with several side effects. However, recent trials have shown that CLND did not improve survival outcomes compared to observation in these patients, which has changed the way clinicians treat melanoma.

To explore this, the Surgical Management survey trial surveyed multiple melanoma centres to examine how clinicians have changed their treatment strategies for Stage III melanoma. This was a global survey, involving regions such as Australia/New Zealand, South America, USA/Canada, Europe and the United Kingdom.

Trial Findings

This study found that there was a dramatic shift in the management of melanoma, with only 5% of surgeons recommending immediate CLND after positive SLNB, a major drop from 92% in 2012. This suggests an increasing adoption of systemic treatments over aggressive surgery, as a result of new evidence from trials.

Main publication

https://pubmed.ncbi.nlm.nih.gov/34406652/

MASC Trials Contact

hello@masc.org.au