Merkel Positron Emission Tomography (PET) Protocol

Phase 2

Completed

• Conditions: Merkel Cell Carcinoma
• Interventions: Drug: Carboplatin; Drug: Etoposide; Radiation: Radiotherapy

• Registration Number: NCT01013779
• Lead Sponsor: Trans Tasman Radiation Oncology Group

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 Description

Not available

Study Timeline

• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Study Start: 2009-12
• Primary Completion: 2021-06
• Study Completion: 2021-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Radiotherapy	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.
Arm A	Carboplatin	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.
Arm A	Etoposide	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.

Primary Outcome Measures

Name	Time	Method
Time to loco-regional failure curve	Minimum of 18 months follow up
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia	Duration of Radiotherapy treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Royal Prince Alfred; 🇦🇺 Sydney, New South Wales, Australia

Royal Brisbane Hospital; 🇦🇺 Herston, Queensland, Australia

Sir Charles Gairdner; 🇦🇺 Nedlands, Western Australia, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Genesis Cancer Care (previously Premion); 🇦🇺 Tugun, Queensland, Australia

Radiation Oncology Services - Mater Centre; 🇦🇺 Brisbane, Queensland, Australia

Princess Alexandra Hospital Radiation Oncology; 🇦🇺 Brisbane, Queensland, Australia

Geelong Hospital; 🇦🇺 Geelong, Victoria, Australia

Oncology Research Australia; 🇦🇺 Toowoomba, Queensland, Australia

Campbelltown; 🇦🇺 Campbelltown, New South Wales, Australia

Liverpool Hospital; 🇦🇺 Liverpool, New South Wales, Australia

Calvary Mater Newcastle; 🇦🇺 Waratah, New South Wales, Australia

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia