Merkel Positron Emission Tomography (PET) Protocol

• Status: Active, not recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Trans Tasman Radiation Oncology Group; Trans-Tasman Radiation Oncology Group (TROG)
• Treatments: Carboplatin; Etoposide; Etoposide phosphate

Criteria

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