Merkel Positron Emission Tomography (PET) Protocol (MP3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Trans-Tasman Radiation Oncology Group (TROG)
Sponsor:
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT01013779
First received: November 12, 2009
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Merkel Cell Carcinoma
Drug: Carboplatin
Drug: Etoposide
Radiation: Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • Time to loco-regional failure curve [ Time Frame: Minimum of 18 months follow up ] [ Designated as safety issue: No ]
  • Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia [ Time Frame: Duration of Radiotherapy treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival and time to distant failure curves [ Time Frame: 3 year acturarial curves ] [ Designated as safety issue: No ]
  • Proportion of patients for which PET can influence management. [ Time Frame: 12 weeks post Radiotherapy ] [ Designated as safety issue: No ]
  • Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET. [ Time Frame: 12 weeks post Radiotherapy ] [ Designated as safety issue: No ]
  • Post-treatment PET complete response rate for patients with unresected disease [ Time Frame: 12 weeks post Radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.

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

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

Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions

Other Names:
  • RT
  • Radiation Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013779

Contacts
Contact: Adrienne See +61 07 3840 3281 adrienne_see@health.qld.gov.au

Locations
Australia, New South Wales
Campbelltown Not yet recruiting
Campbelltown, New South Wales, Australia
Contact: Dion Forstner    +61 2 98285234      
Principal Investigator: Dion Forstner         
Liverpool Hospital Not yet recruiting
Liverpool, New South Wales, Australia
Contact: Dion Forstner    +61 2 98285234      
Principal Investigator: Dion Forstner         
Royal Prince Alfred Recruiting
Sydney, New South Wales, Australia
Contact: George Hruby         
Principal Investigator: G Hruby         
Calvary Mater Newcastle Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Mahesh Kumar         
Principal Investigator: M Kumar         
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Michael Neness    +61 2 9845 5200    michael.veness@swahs.health.nsw.gov.au   
Principal Investigator: Michael Veness         
Australia, Queensland
Princess Alexandra Hospital Radiation Oncology Recruiting
Brisbane, Queensland, Australia
Contact: Matthew Foote    +61 7 31763067      
Principal Investigator: Matthew Foote         
Radiation Oncology Services - Mater Centre Recruiting
Brisbane, Queensland, Australia, 4101
Contact: Michael Poulsen    +61 7 3840 3255    michael_poulsen@health.qld.gov.au   
Principal Investigator: Michael Poulsen         
Royal Brisbane Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Graeme Dickie         
Principal Investigator: Graeme Dickie         
Oncology Research Australia Recruiting
Toowoomba, Queensland, Australia, 4350
Contact: Michael Poulsen    +61 7 46145811      
Principal Investigator: M Poulsen         
Premion Recruiting
Tugun, Queensland, Australia, 4224
Contact: David Christie         
Principal Investigator: D Christie         
Australia, Victoria
Geelong Hospital Recruiting
Geelong, Victoria, Australia
Contact: Rod Lynch         
Principal Investigator: Rod Lynch         
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Andrew Hui    +610396561804      
Principal Investigator: A Hui         
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
Study Chair: Michael Poulsen Trans-Tasman Radiation Oncology Group (TROG)
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT01013779     History of Changes
Other Study ID Numbers: TROG 09.03, ACTRN12610000480088
Study First Received: November 12, 2009
Last Updated: July 31, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Merkel Cell Cancer
PET scanning

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Merkel Cell
Adenocarcinoma
Carcinoma, Neuroendocrine
DNA Virus Infections
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Polyomavirus Infections
Tumor Virus Infections
Virus Diseases
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014