Trial record 2 of 6 for:
Open Studies | "Carcinoma, Merkel Cell"
Merkel Positron Emission Tomography (PET) Protocol (MP3)
This study is currently recruiting participants.
Verified February 2013 by Trans-Tasman Radiation Oncology Group (TROG)
Sponsor:
Trans-Tasman Radiation Oncology Group (TROG)
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT01013779
First received: November 12, 2009
Last updated: February 12, 2013
Last verified: February 2013
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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: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (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. 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:
|
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:
- 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
Contacts and Locations
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 | |
| 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 | |
| Princess Alexandra Hospital Radiation Oncology | Recruiting |
| Brisbane, Queensland, Australia | |
| Contact: Matthew Foote +61 7 31763067 | |
| Principal Investigator: Matthew Foote | |
| 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: | February 12, 2013 |
| 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, Merkel Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Neuroendocrine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Adenocarcinoma Neoplasms, Nerve Tissue Etoposide Etoposide phosphate Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013