Merkel Cell CarcinomaPhase 2MP3NCT01013779
Merkel Positron Emission Tomography (PET) Protocol
A Phase 2 study testing Carboplatin, Etoposide and Radiotherapy in people with Merkel Cell Carcinoma, run by Trans Tasman Radiation Oncology Group at 13 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Merkel Cell Carcinoma
- What is being tested?
- Carboplatin, Etoposide and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 13 sitesAustralia
- Study dates
- Dec 2009to Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Australia13 sites
Radiation Oncology Services - Mater Centre
Brisbane, Queensland, 4101
Princess Alexandra Hospital Radiation Oncology
Brisbane, Queensland
Campbelltown
Campbelltown, New South Wales
Geelong Hospital
Geelong, Victoria
Royal Brisbane Hospital
Herston, Queensland, 4029
Liverpool Hospital
Liverpool, New South Wales
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Sir Charles Gairdner
Nedlands, Western Australia, 6009
Royal Prince Alfred
Sydney, New South Wales
Oncology Research Australia
Toowoomba, Queensland, 4350
Genesis Cancer Care (previously Premion)
Tugun, Queensland, 4224
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Westmead Hospital
Westmead, New South Wales, 2145
About this study
Official title: A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
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.
- Conditions
- Merkel Cell Carcinoma
- Being tested
- Carboplatin, Etoposide, Radiotherapy
- Keywords
- Merkel Cell Cancer, PET scanning
- Medical subject headings
- Carcinoma, Merkel Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
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.
EtoposideDrug
After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3
RadiotherapyRadiation
Also called RT, Radiation Therapy
Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions
Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Drug: Carboplatin; Drug: Etoposide; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to loco-regional failure curve
Measured: Minimum of 18 months follow up
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
Measured: Duration of Radiotherapy treatment
Secondary outcomes (4)
Overall survival and time to distant failure curves
Measured: 3 year acturarial curves
Proportion of patients for which PET can influence management.
Measured: 12 weeks post Radiotherapy
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
Measured: 12 weeks post Radiotherapy
Post-treatment PET complete response rate for patients with unresected disease
Measured: 12 weeks post Radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Merkel Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Poulsen, Study chair, Trans Tasman Radiation Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013779
- Sponsor's protocol ID
- TROG 09.03
- Other IDs
- ACTRN12610000480088
- Acronym
- MP3
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2009
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Efficacy Study of Chemo-Radiotherapy in PET Stage II and III Merkel Cell Carcinoma of the Skin
- ClinicalTrials.gov ID
- NCT01013779
- Acronym / sponsor ID
- MP3 / TROG 09.03
- Conditions
- Merkel Cell Carcinoma
- Keywords
- Merkel Cell Cancer, PET scanning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Study start
- Dec 2009 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 16 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Carboplatin, Drug: Etoposide, Radiation: RadiotherapyConventional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinDuring 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 | Arm A |
| EtoposideAfter Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3 | Drug | Arm A |
| RadiotherapyAlso: RT, Radiation TherapyMicroscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions | Radiation | Arm A |
Primary outcome
Time to loco-regional failure curve
Time frame: Minimum of 18 months follow up
Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia
Time frame: Duration of Radiotherapy treatment
4 secondary outcomes
Overall survival and time to distant failure curves
Time frame: 3 year acturarial curves
Proportion of patients for which PET can influence management.
Time frame: 12 weeks post Radiotherapy
Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.
Time frame: 12 weeks post Radiotherapy
Post-treatment PET complete response rate for patients with unresected disease
Time frame: 12 weeks post Radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- please visit this website for further trial specific informationLink provided by the sponsor.
Related trials for Merkel Cell Carcinoma
Active, not recruitingPhase 3
Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP Trial
Pathologic Stage I Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage II Cutaneous Merkel Cell Carcinoma AJCC v8
RecruitingPhase 1
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
Advanced Or Metastatic Merkel Cell Carcinoma
Active, not recruitingPhase 1
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
RecruitingPhase 1/2
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
RecruitingPhase 1/2
A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Poulsen study chair
Trans Tasman Radiation Oncology Group
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Etoposide and Radiotherapy in people with Merkel Cell Carcinoma, run by Trans Tasman Radiation Oncology Group at 13 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to loco-regional failure curve (time frame: Minimum of 18 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.