Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2009-12-31
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Etoposide
After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
Radiotherapy
Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions
Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions
Interventions
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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.
Etoposide
After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
Radiotherapy
Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions
Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Trans Tasman Radiation Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Michael Poulsen
Role: STUDY_CHAIR
Trans Tasman Radiation Oncology Group
Locations
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Campbelltown
Campbelltown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal Prince Alfred
Sydney, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Radiation Oncology Services - Mater Centre
Brisbane, Queensland, Australia
Princess Alexandra Hospital Radiation Oncology
Brisbane, Queensland, Australia
Royal Brisbane Hospital
Herston, Queensland, Australia
Oncology Research Australia
Toowoomba, Queensland, Australia
Genesis Cancer Care (previously Premion)
Tugun, Queensland, Australia
Geelong Hospital
Geelong, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner
Nedlands, Western Australia, Australia
Countries
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Related Links
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please visit this website for further trial specific information
Other Identifiers
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ACTRN12610000480088
Identifier Type: REGISTRY
Identifier Source: secondary_id
TROG 09.03
Identifier Type: -
Identifier Source: org_study_id
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