- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013779
Merkel Positron Emission Tomography (PET) Protocol (MP3)
A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Campbelltown, New South Wales, Australia
- Campbelltown
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Liverpool, New South Wales, Australia
- Liverpool Hospital
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Sydney, New South Wales, Australia
- Royal Prince Alfred
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Waratah, New South Wales, Australia, 2298
- Calvary Mater Newcastle
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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Queensland
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Brisbane, Queensland, Australia, 4101
- Radiation Oncology Services - Mater Centre
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Brisbane, Queensland, Australia
- Princess Alexandra Hospital Radiation Oncology
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Herston, Queensland, Australia, 4029
- Royal Brisbane Hospital
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Toowoomba, Queensland, Australia, 4350
- Oncology Research Australia
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Tugun, Queensland, Australia, 4224
- Genesis Cancer Care (previously Premion)
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Victoria
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Geelong, Victoria, Australia
- Geelong Hospital
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Melbourne, Victoria, Australia, 3000
- Peter MacCallum Cancer Centre
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Active infection
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to loco-regional failure curve
Time Frame: Minimum of 18 months follow up
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Minimum of 18 months follow up
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Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
Time Frame: Duration of Radiotherapy treatment
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Duration of Radiotherapy treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival and time to distant failure curves
Time Frame: 3 year acturarial curves
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3 year acturarial curves
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Proportion of patients for which PET can influence management.
Time Frame: 12 weeks post Radiotherapy
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12 weeks post Radiotherapy
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Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
Time Frame: 12 weeks post Radiotherapy
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12 weeks post Radiotherapy
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Post-treatment PET complete response rate for patients with unresected disease
Time Frame: 12 weeks post Radiotherapy
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12 weeks post Radiotherapy
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Collaborators and Investigators
Investigators
- Study Chair: Michael Poulsen, Trans Tasman Radiation Oncology Group
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Neoplasms by Histologic Type
- Neoplasms
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- DNA Virus Infections
- Tumor Virus Infections
- Neuroendocrine Tumors
- Polyomavirus Infections
- Carcinoma, Neuroendocrine
- Carcinoma
- Carcinoma, Merkel Cell
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Carboplatin
- Etoposide
Other Study ID Numbers
- TROG 09.03
- ACTRN12610000480088 (Registry Identifier: ANZCTR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Merkel Cell Carcinoma
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National Cancer Institute (NCI)Active, not recruitingAdvanced Merkel Cell Carcinoma | Metastatic Merkel Cell Carcinoma | Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 | Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 | Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8 | Pathologic Stage IIIA Cutaneous Merkel... and other conditionsUnited States
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National Cancer Institute (NCI)RecruitingMetastatic Merkel Cell Carcinoma | Refractory Merkel Cell Carcinoma | Locally Advanced Merkel Cell Carcinoma | Unresectable Merkel Cell Carcinoma | Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 | Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8United States
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National Cancer Institute (NCI)CompletedRecurrent Merkel Cell Carcinoma | Stage III Merkel Cell Carcinoma AJCC v7 | Stage IV Merkel Cell Carcinoma AJCC v7 | Stage IIIA Merkel Cell Carcinoma AJCC v7 | Stage IIIB Merkel Cell Carcinoma AJCC v7United States
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Melanoma and Skin Cancer Trials LimitedRecruitingNeuroendocrine Tumors | Merkel Cell Carcinoma | Merkel Cell Carcinoma, Stage I | Merkel Cell Carcinoma, Stage II | Merkel Cell Carcinoma, Stage III | Carcinoma Neuroendocrine SkinAustralia, New Zealand
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University of WashingtonEMD SeronoActive, not recruitingStage III Merkel Cell Carcinoma AJCC v8 | Stage IIIB Merkel Cell Carcinoma AJCC v8 | Stage IIIA Merkel Cell Carcinoma AJCC v8United States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Merkel Cell Carcinoma | Stage IV Merkel Cell CarcinomaUnited States
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National Cancer Institute (NCI)SuspendedPathologic Stage I Cutaneous Merkel Cell Carcinoma AJCC v8 | Pathologic Stage II Cutaneous Merkel Cell Carcinoma AJCC v8 | Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8United States
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ImmunityBio, Inc.UnknownStage IIIB Merkel Cell Carcinoma | Stage IV Merkel Cell CarcinomaUnited States
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University of WashingtonIncyte CorporationRecruitingMerkel Cell Carcinoma | Clinical Stage IV Merkel Cell Carcinoma AJCC v8 | Unresectable Clinical Stage III Merkel Cell Carcinoma AJCC v8United States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); EMD SeronoTerminatedStage IV Merkel Cell Carcinoma AJCC v7 | Merkel Cell Polyomavirus InfectionUnited States
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