A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will undergo PET scans to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
During radiotherapy: Carboplatin (AUC2) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation). After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (AUC4.5) intravenously on day 1.
After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions
Campbelltown
Campbelltown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal Prince Alfred
Sydney, New South Wales, Australia
Time to loco-regional failure curve
Time frame: Minimum of 18 months follow up
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
Time frame: Duration of Radiotherapy treatment
Overall survival and time to distant failure curves
Time frame: 3 year acturarial curves
Proportion of patients for which PET can influence management.
Time frame: 12 weeks post Radiotherapy
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
Time frame: 12 weeks post Radiotherapy
Post-treatment PET complete response rate for patients with unresected disease
Time frame: 12 weeks post Radiotherapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Radiation Oncology Services - Mater Centre
Brisbane, Queensland, Australia
Princess Alexandra Hospital Radiation Oncology
Brisbane, Queensland, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia
Oncology Research Australia
Toowoomba, Queensland, Australia
Genesis Cancer Care (previously Premion)
Tugun, Queensland, Australia
...and 3 more locations