Merkel Positron Emission Tomography (PET) Protocol

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:

• Active infection
• 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