Radiotherapy & Combi in Metastatic Melanoma (CombiRT)
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|ClinicalTrials.gov Identifier: NCT02392871|
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : June 29, 2017
The purpose of this study is to investigate the side effects and safety, and effectiveness of combining dabrafenib and trametinib with radiotherapy.
Previous and ongoing clinical trials have demonstrated the effectiveness and safety of combining both dabrafenib and trametinib compared with dabrafenib alone. This has led to the approval for the use of both drugs in combination in people with metastatic melanoma with the BRAF mutation. Melanoma that has spread to other parts of the body may also benefit from radiotherapy to help reduce symptoms from melanoma. Previous studies have shown that melanoma may be sensitive to radiotherapy and that it can help to improve quality of life.
The intention of the CombiRT study is to establish if dabrafenib, trametinib and radiotherapy combined is a safe and effective treatment for metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Radiation: Palliative radiotherapy Drug: Dabrafenib and trametinib (combination)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
Palliative radiotherapy in combination with dabrafenib and trametinib Eligible subjects are patients who have been on dabrafenib and trametinib for more than 2 weeks, as the current standard management for advanced stage melanoma.
Palliative RT will be delivered to symptomatic or bulky (>2cm) soft tissue, nodal or bony metastases concurrently with dabrafenib and trametinib. Up to 3 areas of disease can be irradiated at the same time.
Following RT, dabrafenib and trametinib alone will be continued until disease progression according to RECIST 1.1 criteria.
Radiation: Palliative radiotherapy
Drug: Dabrafenib and trametinib (combination)
Patients should be taking dabrafenib and trametinib for at least 2 weeks prior to enrolment into the study.
- Toxicity profile for patients receiving dabrafenib and trametinib in combination with RT, by measuring adverse events and radiotherapy associated toxicities. [ Time Frame: 0-12 months ]
- Patients' pain using a visual analog scale (questionnaire) [ Time Frame: 0-12 months ]
- Overall disease response by measuring progression free survival and overall survival. [ Time Frame: 0-12 months ]
- Local treatment response in the irradiated index lesion(s). [ Time Frame: 0-12 months ]
- Time to local progression in the irradiated index lesion(s). [ Time Frame: 0-12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392871
|Contact: ANZMTG Coordinator||612 9911 email@example.com|
|Australia, New South Wales|
|St Vincent's Hospital||Recruiting|
|Darlinghurst, New South Wales, Australia, 2010|
|Contact: Ashley Douglas Ashley.Douglas@svha.org.au|
|Principal Investigator: Gerald Fogarty, MBBS|
|Sub-Investigator: Anthony Joshua, MBBS|
|Sydney, New South Wales, Australia, 2145|
|Contact: Tracy Pearl-Larsson Tracy.Pearl-Larson@health.nsw.gov.au|
|Principal Investigator: Tim Wang, MBBS|
|Sub-Investigator: Matteo Carlino, MBBS|
|Princess Alexandra Hospital||Recruiting|
|Brisbane, Queensland, Australia, 4102|
|Contact: Adrienne See firstname.lastname@example.org|
|Principal Investigator: Matthew Foote, MBBS|
|Principal Investigator:||Tim Wang||Westmead Hospital|