Clinical Trial: Merkel Positron Emission Tomography (PET) Protocol
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
Brief 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.
Detailed Summary:
Sponsor: Trans-Tasman Radiation Oncology Group (TROG)
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Trans-Tasman Radiation Oncology Group (TROG)
Dates:
Date Received: November 12, 2009
Date Started: December 2009
Date Completion: December 2020
Last Updated: January 22, 2017
Last Verified: January 2017
