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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01013779




Registration number
NCT01013779
Ethics application status
Date submitted
12/11/2009
Date registered
16/11/2009
Date last updated
18/11/2022

Titles & IDs
Public title
Merkel Positron Emission Tomography (PET) Protocol
Scientific title
A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
Secondary ID [1] 0 0
ACTRN12610000480088
Secondary ID [2] 0 0
TROG 09.03
Universal Trial Number (UTN)
Trial acronym
MP3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Merkel Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carboplatin
Treatment: Drugs - Etoposide
Treatment: Other - Radiotherapy

Experimental: Arm A - 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: Drugs: Carboplatin
During radiotherapy: Carboplatin (AUC2) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation).

After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (AUC4.5) intravenously on day 1.

Treatment: Drugs: Etoposide
After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3

Treatment: Other: Radiotherapy
Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions

Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to loco-regional failure curve
Timepoint [1] 0 0
Minimum of 18 months follow up
Primary outcome [2] 0 0
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
Timepoint [2] 0 0
Duration of Radiotherapy treatment
Secondary outcome [1] 0 0
Overall survival and time to distant failure curves
Timepoint [1] 0 0
3 year acturarial curves
Secondary outcome [2] 0 0
Proportion of patients for which PET can influence management.
Timepoint [2] 0 0
12 weeks post Radiotherapy
Secondary outcome [3] 0 0
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
Timepoint [3] 0 0
12 weeks post Radiotherapy
Secondary outcome [4] 0 0
Post-treatment PET complete response rate for patients with unresected disease
Timepoint [4] 0 0
12 weeks post Radiotherapy

Eligibility
Key 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 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2021
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Campbelltown - Campbelltown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Royal Prince Alfred - Sydney
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Radiation Oncology Services - Mater Centre - Brisbane
Recruitment hospital [7] 0 0
Princess Alexandra Hospital Radiation Oncology - Brisbane
Recruitment hospital [8] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [9] 0 0
Oncology Research Australia - Toowoomba
Recruitment hospital [10] 0 0
Genesis Cancer Care (previously Premion) - Tugun
Recruitment hospital [11] 0 0
Geelong Hospital - Geelong
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [13] 0 0
Sir Charles Gairdner - Nedlands
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4101 - Brisbane
Recruitment postcode(s) [7] 0 0
- Brisbane
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
4350 - Toowoomba
Recruitment postcode(s) [10] 0 0
4224 - Tugun
Recruitment postcode(s) [11] 0 0
- Geelong
Recruitment postcode(s) [12] 0 0
3000 - Melbourne
Recruitment postcode(s) [13] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01013779
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Poulsen
Address 0 0
Trans Tasman Radiation Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01013779