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Merkel Positron Emission Tomography (PET) Protocol (MP3)

Primary Purpose

Merkel Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Carboplatin
Etoposide
Radiotherapy
Sponsored by
Trans Tasman Radiation Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Merkel Cell Carcinoma focused on measuring Merkel Cell Cancer, PET scanning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Campbelltown
  • Liverpool Hospital
  • Royal Prince Alfred
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Radiation Oncology Services - Mater Centre
  • Princess Alexandra Hospital Radiation Oncology
  • Royal Brisbane Hospital
  • Oncology Research Australia
  • Genesis Cancer Care (previously Premion)
  • Geelong Hospital
  • Peter MacCallum Cancer Centre
  • Sir Charles Gairdner

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to loco-regional failure curve
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia

Secondary Outcome Measures

Overall survival and time to distant failure curves
Proportion of patients for which PET can influence management.
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
Post-treatment PET complete response rate for patients with unresected disease

Full Information

First Posted
November 12, 2009
Last Updated
November 17, 2022
Sponsor
Trans Tasman Radiation Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT01013779
Brief Title
Merkel Positron Emission Tomography (PET) Protocol
Acronym
MP3
Official Title
A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 2009 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trans Tasman Radiation Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Merkel Cell Carcinoma
Keywords
Merkel Cell Cancer, PET scanning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
RT, Radiation Therapy
Intervention Description
Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions
Primary Outcome Measure Information:
Title
Time to loco-regional failure curve
Time Frame
Minimum of 18 months follow up
Title
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
Time Frame
Duration of Radiotherapy treatment
Secondary Outcome Measure Information:
Title
Overall survival and time to distant failure curves
Time Frame
3 year acturarial curves
Title
Proportion of patients for which PET can influence management.
Time Frame
12 weeks post Radiotherapy
Title
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
Time Frame
12 weeks post Radiotherapy
Title
Post-treatment PET complete response rate for patients with unresected disease
Time Frame
12 weeks post Radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Poulsen
Organizational Affiliation
Trans Tasman Radiation Oncology Group
Official's Role
Study Chair
Facility Information:
Facility Name
Campbelltown
City
Campbelltown
State/Province
New South Wales
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Royal Prince Alfred
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Radiation Oncology Services - Mater Centre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital Radiation Oncology
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Brisbane Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Oncology Research Australia
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Facility Name
Genesis Cancer Care (previously Premion)
City
Tugun
State/Province
Queensland
ZIP/Postal Code
4224
Country
Australia
Facility Name
Geelong Hospital
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Sir Charles Gairdner
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://www.trog.com.au
Description
please visit this website for further trial specific information

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Merkel Positron Emission Tomography (PET) Protocol

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