A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
Overview
- Phase
- Phase 2
- Intervention
- Carboplatin
- Conditions
- Merkel Cell Carcinoma
- Sponsor
- Trans Tasman Radiation Oncology Group
- Enrollment
- 43
- Locations
- 13
- Primary Endpoint
- Time to loco-regional failure curve
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A
Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.
Intervention: Carboplatin
Arm A
Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.
Intervention: Etoposide
Arm A
Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.
Intervention: Radiotherapy
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Overall survival and time to distant failure curves(3 year acturarial curves)
- Proportion of patients for which PET can influence management.(12 weeks post Radiotherapy)
- Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.(12 weeks post Radiotherapy)
- Post-treatment PET complete response rate for patients with unresected disease(12 weeks post Radiotherapy)