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

Phase 2
18 Years
Open (Enrolling)
Merkel Cell Carcinoma

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Trial Information

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

Inclusion 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to loco-regional failure curve

Outcome Time Frame:

Minimum of 18 months follow up

Safety Issue:


Principal Investigator

Michael Poulsen

Investigator Role:

Study Chair

Investigator Affiliation:

Trans-Tasman Radiation Oncology Group (TROG)


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

TROG 09.03



Start Date:

December 2009

Completion Date:

December 2015

Related Keywords:

  • Merkel Cell Carcinoma
  • Merkel Cell Cancer
  • PET scanning
  • Carcinoma
  • Carcinoma, Merkel Cell