ActivePhase 2ACTRN12610000480088

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


Sponsor

Trans Tasman Radiation Oncology Group (TROG)

Enrollment

50 participants

Start Date

Jun 2, 2010

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether combining chemotherapy with radiation therapy is effective for Merkel cell carcinoma, a rare and aggressive skin cancer. It is for adults aged 18 and over with high-risk Merkel cell carcinoma that has not spread to distant parts of the body. People with evidence of distant spread, a weakened immune system, or who have had chemotherapy in the past 5 years are not eligible.

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

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)

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,WA,VIC, Australia

St Andrew's Toowoomba Hospital - Toowoomba

NSW,QLD,WA,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,QLD,WA,VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

NSW,QLD,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,WA,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,WA,VIC, Australia

Peter MacCallum Cancer Institute - East Melbourne

NSW,QLD,WA,VIC, Australia

Calvary Mater Newcastle - Waratah

NSW,QLD,WA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,QLD,WA,VIC, Australia

Campbelltown Hospital - Campbelltown

NSW,QLD,WA,VIC, Australia

Mater Adult Hospital - South Brisbane

NSW,QLD,WA,VIC, Australia

Sir Charles Gairdner Hospital - Nedlands

NSW,QLD,WA,VIC, Australia

Genesis Cancer Care QLD - Tugun

NSW,QLD,WA,VIC, Australia

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