Merkel Positron Emission Tomography (PET) Protocol (MP3)

Trans Tasman Radiation Oncology Group

Status and phase: Completed; Phase 2

Conditions: Merkel Cell Carcinoma

Treatments: Radiation: Radiotherapy; Drug: Etoposide; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01013779

TROG 09.03

ACTRN12610000480088 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Arm A

Experimental group

Description:

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.

Treatment:

Drug: Etoposide

Drug: Carboplatin

Radiation: Radiotherapy