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Trial registered on ANZCTR


Registration number
ACTRN12610000480088
Ethics application status
Approved
Date submitted
3/12/2009
Date registered
10/06/2010
Date last updated
13/03/2020
Date data sharing statement initially provided
10/12/2019
Date results provided
10/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An efficacy study of Chemo-Radiotherapy in Positron Emission Tomography (PET) Merkel Cell Carcinoma of the Skin
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 09.03 - A Phase II Efficacy Study of Chemo-Radiotherapy in Positron Emission Tomography (PET) Stage II and III Merkel Cell Carcinoma of the Skin
Secondary ID [1] 1170 0
ClinicalTrials.gov ID NCT01013779
Universal Trial Number (UTN)
Trial acronym
MP3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Merkel Cell Carcinoma 252338 0
Condition category
Condition code
Cancer 252527 252527 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Experimental. Treatment: drugs - Carboplatin. During Radiotherapy: Carboplatin (dose calculated using Calvert formula with Area Under the Curve (AUC) 2.0) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation). Carboplatin is administered intravenously over 20-30 minutes.
After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (dose calculated using Calvert formula using AUC4.5) intravenously on day 1.

Treatment: drugs - Etoposide. After radiotherapy: 3 weeks after completion of radiotherapy, 3 cycles of 3 weekly etoposide (80mg/m2/day), given intravenously days 1-3.

Treatment: other - Radiotherapy. Micrscopic Disease: 50 Gy in 2Gy doses over 25 fractions (5 weeks).
Macroscopic Disease: 54 Gy in 2Gy doses over 27 fractions (5 1/2 weeks).
Intervention code [1] 255649 0
Treatment: Drugs
Intervention code [2] 255650 0
Treatment: Other
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253409 0
Time to loco-regional Failure curve. Measure of the effectiveness of treatment at the primary and nodal sites. Measured through imaging madality such as Computed Tomography (CT), PET or bone scan.
Timepoint [1] 253409 0
Measured from date of registration to time of failure. Patients will be assessed at baseline, weekly during treatment, 9 weeks post radiotherapy, 3 monthly for 2 years, 4 monthly for 1 year and 6 monthly for 2 years.
Primary outcome [2] 253410 0
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia. Measured using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTC AE) v 4.0.
Timepoint [2] 253410 0
Assessed weekly ( 5 weeks) during radiotherapy and Chemotherapy (at 3, 6 and 9 weeks post radiotherapy)
Secondary outcome [1] 262515 0
Overall survival (OS) and time to distant failure curves. OS measures the proportion of patients who die from any cause; time to distant failure measures proportion of patients who develop metastatic disease.
Measured upon relapse, diagnosis by clinical assessment confirmed by pathology or imaging (assessment at discretion of treating centre)
Timepoint [1] 262515 0
From date of registration to 5 years post registration. Patients will be assessed at baseline, weekly during treatment, 9 weeks post radiotherapy, 3 monthly for 2 years, 4 monthly for 1 year and 6 monthly for 2 years.
Secondary outcome [2] 262516 0
Proportion of patients for which PET can influence management. Measured by comparing initial Computed Tomography (CT) staging scan and PET imaging.
Timepoint [2] 262516 0
12 weeks post radiotherapy
Secondary outcome [3] 262517 0
Positive Predictaive Value (PPV) and Negative Predictive Value (NPV) of PET. This will measure the accuracy of PET in detecting Merkell Cell Carcinoma.
Timepoint [3] 262517 0
12 weeks post radiotherapy
Secondary outcome [4] 262518 0
Post-Treatment PET complete response rate for patients with unresected disease. Measured by Post Treatment PET scan.
Timepoint [4] 262518 0
12 weeks post radiotherapy

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prior to patient enrolment, the investigator should ensure that all of the following
requirements are met:
· The patient meets all inclusion criteria and none of the exclusion criteria should apply.
· The patient has signed and dated all applicable consent forms.
· All baseline assessments and investigations have been performed.
· The eligibility checklist has been completed, signed and dated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/06/2010
Actual
2/06/2010
Date of last participant enrolment
Anticipated
31/01/2016
Actual
20/01/2016
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
50
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 1698 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 1699 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment hospital [3] 1700 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 1701 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [5] 1702 0
Westmead Hospital - Westmead
Recruitment hospital [6] 1703 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 1704 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [8] 1705 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [9] 1706 0
Liverpool Hospital - Liverpool
Recruitment hospital [10] 1707 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [11] 4183 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [12] 4184 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [13] 4185 0
Genesis Cancer Care QLD - Tugun
Recruitment postcode(s) [1] 8470 0
4101 - South Brisbane
Recruitment postcode(s) [2] 8471 0
4350 - Toowoomba
Recruitment postcode(s) [3] 8475 0
4224 - Tugun
Recruitment postcode(s) [4] 10090 0
4006 - Herston
Recruitment postcode(s) [5] 10091 0
2570 - Camden
Recruitment postcode(s) [6] 10092 0
2170 - Liverpool
Recruitment postcode(s) [7] 10093 0
2050 - Camperdown
Recruitment postcode(s) [8] 10094 0
3220 - Geelong
Recruitment postcode(s) [9] 10095 0
2145 - Westmead
Recruitment postcode(s) [10] 10096 0
4102 - Woolloongabba
Recruitment postcode(s) [11] 10097 0
3002 - East Melbourne
Recruitment postcode(s) [12] 10098 0
2298 - Waratah
Recruitment postcode(s) [13] 10099 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 256129 0
Government body
Name [1] 256129 0
Cancer Australia and Cancer Council
Country [1] 256129 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
TROG Central Office
PO Box 88
Waratah NSW 2298
Country
Australia
Secondary sponsor category [1] 290484 0
None
Name [1] 290484 0
Address [1] 290484 0
Country [1] 290484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258218 0
Princess Alexandra Hospital Ethics Committee
Ethics committee address [1] 258218 0
Ethics committee country [1] 258218 0
Australia
Date submitted for ethics approval [1] 258218 0
Approval date [1] 258218 0
23/11/2009
Ethics approval number [1] 258218 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30578 0
A/Prof Michael Poulsen
Address 30578 0
Radiation Oncology – Mater Centre
31 Raymond Terrace
South Brisbane , QLD
4101
Country 30578 0
Australia
Phone 30578 0
+ 61 7 3840 3255
Fax 30578 0
Email 30578 0
michael_poulsen@health.qld.gov.au
Contact person for public queries
Name 13825 0
Narelle Wallace
Address 13825 0
Radiation Oncology – Mater Centre 31 Raymond Tce South Brisbane QLD 4101
Country 13825 0
Australia
Phone 13825 0
+61 7 3840 3322
Fax 13825 0
+61 7 3840 3298
Email 13825 0
narelle.wallace2@health.qld.gov.au
Contact person for scientific queries
Name 4753 0
Narelle Wallace
Address 4753 0
Radiation Oncology – Mater Centre
31 Raymond Tce
South Brisbane QLD 4101
Country 4753 0
Australia
Phone 4753 0
+61 7 3840 3322
Fax 4753 0
Email 4753 0
narelle.wallace2@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
Documents were uploaded by study researchers but have since been removed.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4278Study results articleYes Published: 05 February 2018 Citation: Poulsen M, ... [More Details]

Documents added automatically
No additional documents have been identified.