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