An efficacy study of Chemo-Radiotherapy in Positron Emission Tomography (PET) Merkel Cell Carcinoma of the Skin
Trans Tasman Radiation Oncology Group (TROG) 09.03 - A Phase II Efficacy Study of Chemo-Radiotherapy in Positron Emission Tomography (PET) Stage II and III Merkel Cell Carcinoma of the Skin
Trans Tasman Radiation Oncology Group (TROG)
50 participants
Jun 2, 2010
Interventional
Conditions
Summary
The overall objective of this study is to develop a well tolerated chemo-radiotherapy regimen for patients with Merkel Cell Carcinoma (MCC) of the skin that achieves high rates of control. You may be eligible to join this study if you are aged 18 or over and have been diagnosed with stage II or stage III Merkel Cell Carcinoma of the skin with no evidence of distant spread. All participants in this study will undergo radiation therapy for 5 days per week for 5 weeks whilst being administered Carboplatin intravenously (i.e. directly into the vein) once per week. Three weeks after the end of radiation therapy, patients will commence 3 x 3-week cycles of intravenous Carboplatin, administered on day 1 of each cycle, and intravenous Etoposide, administered on days 1-3 of each cycle. Patients will be assessed by PET scan, CT and/or bone scan, and monitored for therapy side effects and survival every 3-6 months for 5 years. The PET scans will be used to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment. It is hoped that the findings of this trial will lead to a greater understanding of the effect and toxicity of Carboplatin-Etoposide chemotherapy in combination with radiation therapy for stage II and III Merkel Cell Carcinoma.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Arm A: Experimental. Treatment: drugs - Carboplatin. During Radiotherapy: Carboplatin (dose calculated using Calvert formula with Area Under the Curve (AUC) 2.0) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation). Carboplatin is administered intravenously over 20-30 minutes. After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (dose calculated using Calvert formula using AUC4.5) intravenously on day 1. Treatment: drugs - Etoposide. After radiotherapy: 3 weeks after completion of radiotherapy, 3 cycles of 3 weekly etoposide (80mg/m2/day), given intravenously days 1-3. Treatment: other - Radiotherapy. Micrscopic Disease: 50 Gy in 2Gy doses over 25 fractions (5 weeks). Macroscopic Disease: 54 Gy in 2Gy doses over 27 fractions (5 1/2 weeks).
Locations(13)
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ACTRN12610000480088