Merkel Positron Emission Tomography (PET) Protocol

Merkel Cell Carcinoma Clinical Trial

— MP3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013779
• Other study ID #: TROG 09.03
• Secondary ID: ACTRN12610000480
• Status: Completed
• Phase: Phase 2
• Start date: December 2009
• Est. completion date: June 2021

Study information

• Verified date: November 2022
• Source: Trans Tasman Radiation Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Trial Registration:

Patients may be registered on the trial only if they meet all of the following criteria:

• Age 18 years or older

• Written informed consent to participate in the study

• Able to undergo 18-FDG PET scan (no uncontrolled diabetes mellitus or severe claustrophobia).

• Available for follow-up.

• Using adequate contraception if capable of child bearing

• Any Merkel Cell carcinoma confined to the primary and/or nodal sites

• ECOG 0-2.

• Full Blood Count (FBC) should be satisfactory ( Haemoglobin > or equal to 10g/dl, neutrophils > or equal to 2.0 x 109 /l and platelets > or equal to 100 x 109 /l) and renal function (GFR > or equal to 50 ml/min) and hepatic function ( ALT < 5 X upper limit normal, bilirubin < 1.5 X upper limit normal)

• Patients must be able to tolerate protocol treatment

Exclusion Criteria for Registration:

• Previous chemotherapy in the past 5 years or prior radiotherapy to the area of concern

• Unable to comply with treatment protocol eg dementia

• Other malignancy in the past 5 years other than non-melanoma skin cancer.

• Women who are pregnant or lactating.

• Clinical evidence of metastatic disease.

• Immunosuppression from long term steroid use or immunosuppressive drugs.

• Any serious illness or medical condition that precludes the safe administration of the chemotherapy including:

1. Active infection

2. Uncontrolled or unstable cardiac disease including unstable angina, myocardial infarction within the last 3 months, and recurrent ventricular arrhythmias

Inclusion Criteria for Treatment Registration:

Patients may proceed to protocol treatment if they meet the following criteria:

• High risk disease with no evidence of distant spread: Biopsy proven MCC with a primary that is > 2cm (T2N0M0= Stage II) and/or regional nodes (any T, N1M0= Stage III); OR Recurrent MCC not previously treated with radiation treatment; Dermal or in-transit metastasis with or without nodes; Occult primary with involved nodes

• Patients who have no metastases on CT or PET scan OR If CT is suggestive of metastases, they must be PET negative

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Merkel Cell Carcinoma

Intervention

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.
• 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

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital Radiation Oncology	Brisbane	Queensland
Australia	Radiation Oncology Services - Mater Centre	Brisbane	Queensland
Australia	Campbelltown	Campbelltown	New South Wales
Australia	Geelong Hospital	Geelong	Victoria
Australia	Royal Brisbane Hospital	Herston	Queensland
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Sir Charles Gairdner	Nedlands	Western Australia
Australia	Royal Prince Alfred	Sydney	New South Wales
Australia	Oncology Research Australia	Toowoomba	Queensland
Australia	Genesis Cancer Care (previously Premion)	Tugun	Queensland
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Trans Tasman Radiation Oncology Group

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to loco-regional failure curve		Minimum of 18 months follow up
Primary	Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia		Duration of Radiotherapy treatment
Secondary	Overall survival and time to distant failure curves		3 year acturarial curves
Secondary	Proportion of patients for which PET can influence management.		12 weeks post Radiotherapy
Secondary	Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.		12 weeks post Radiotherapy
Secondary	Post-treatment PET complete response rate for patients with unresected disease		12 weeks post Radiotherapy

External Links

•   please visit this website for further trial specific information