An efficacy study of Chemo-Radiotherapy in Positron Emission Tomography (PET) Merkel Cell Carcinoma of the Ski

Phase 2

Active, not recruiting

• Conditions: Merkel Cell Carcinoma; Cancer - Non melanoma skin cancer

• Registration Number: ACTRN12610000480088
• Lead Sponsor: Trans Tasman Radiation Oncology Group (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-10
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients may be included in 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-Fluoro Deoxy Clucose (FDG) PET scan (no uncontrolled diabetes mellitus or severe
claustrophobia).
· Available for follow-up.
· Using adequate contraception if capable of child bearing
· High risk disease with no evidence of distant spread: Biopsy proven Merkel Cell Carcinoma (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
· Eastern Cooperative Oncology Group (ECOG) 0-2.
· Full Blood Count (FBC) should be satisfactory ( Haemoglobin > 10g/dl, neutrophils > 2.0 x 109 /l and platelets > 100 x 109 /l) and renal function (Glomerular Filtration Rate (GFR) > 50 ml/min) and hepatic function (Alanine aminotransferase (ALT) < 5 X upper limit normal, bilirubin < 1.5 X upper limit normal)
· No evidence of metastases on CT staging; OR If CT is suggestive of multiple metastases, they must be PET negative.
· No evidence of other malignancy in the past 5 years other than non-melanoma skin
cancer

Exclusion Criteria

Patients who fulfil any of the following criteria are not eligible for admission to the trial:
· 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.
· Chest CT showing multiple nodules greater than 10mm which are PET positive.
· Any serious illness or medical condition that precludes the safe administration of the chemotherapy including:
(a) Active infection
(b) Uncontrolled or unstable cardiac disease including unstable angina, myocardial infarction within the last 3 months, and recurrent ventricular arrhythmias

Study & Design

• Study Type: Interventional
• Study Design: Not specified