Clinical trial NCT01013779: Merkel Positron Emission Tomography (PET) Protocol
Official title: A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Merkel Cell Carcinoma
Keywords: Merkel Cell Cancer
PET scanning
Lead sponsor: Trans Tasman Radiation Oncology Group
Sponsor class: OTHER
First posted: 2009-11-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Time to loco-regional failure curve
timeFrame: Minimum of 18 months follow up
measure: Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
timeFrame: Duration of Radiotherapy treatment
Secondary outcomes:
measure: Overall survival and time to distant failure curves
timeFrame: 3 year acturarial curves
measure: Proportion of patients for which PET can influence management.
timeFrame: 12 weeks post Radiotherapy
measure: Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
timeFrame: 12 weeks post Radiotherapy
measure: Post-treatment PET complete response rate for patients with unresected disease
timeFrame: 12 weeks post Radiotherapy
Other outcomes:
Locations:
city: Campbelltown
country: Australia
facility: Campbelltown
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Radiation Oncology Services - Mater Centre
state: Queensland
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital Radiation Oncology
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane Hospital
state: Queensland
city: Toowoomba
country: Australia
facility: Oncology Research Australia
state: Queensland
city: Tugun
country: Australia
facility: Genesis Cancer Care (previously Premion)
state: Queensland
city: Geelong
country: Australia
facility: Geelong Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner
state: Western Australia
Study officials:
affiliation: Trans Tasman Radiation Oncology Group
name: Michael Poulsen
role: STUDY_CHAIR
References: