NCT01013779

Merkel Positron Emission Tomography (PET) Protocol

A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Carboplatin	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.
DRUG	Etoposide	After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
RADIATION	Radiotherapy	Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions

Timeline

• Start date: 2009-12-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2009-11-16
• Last updated: 2022-11-18

Locations

13 sites across 1 country: Australia