Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12610000480088 | Registry Identifier | ANZCTR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to loco-regional failure curve | Minimum of 18 months follow up | |
| Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia | Duration of Radiotherapy treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival and time to distant failure curves | 3 year acturarial curves | |
| Proportion of patients for which PET can influence management. | 12 weeks post Radiotherapy | |
Not provided
Inclusion Criteria for Trial Registration:
Patients may be registered on the trial only if they meet all of the following criteria:
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:
Inclusion Criteria for Treatment Registration:
Patients may proceed to protocol treatment if they meet the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Poulsen | Trans Tasman Radiation Oncology Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campbelltown | Campbelltown | New South Wales | Australia | |||
| Liverpool Hospital |
Not provided
| Label | URL |
|---|---|
| please visit this website for further trial specific information | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D015266 | Carcinoma, Merkel Cell |
| ID | Term |
|---|---|
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Etoposide | Drug | After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3 |
|
| Radiotherapy | Radiation | Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions |
|
|
| Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET. |
| 12 weeks post Radiotherapy |
| Post-treatment PET complete response rate for patients with unresected disease | 12 weeks post Radiotherapy |
| Liverpool |
| New South Wales |
| Australia |
| Royal Prince Alfred | Sydney | New South Wales | Australia |
| Calvary Mater Newcastle | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Radiation Oncology Services - Mater Centre | Brisbane | Queensland | 4101 | Australia |
| Princess Alexandra Hospital Radiation Oncology | Brisbane | Queensland | Australia |
| Royal Brisbane Hospital | Herston | Queensland | 4029 | Australia |
| Oncology Research Australia | Toowoomba | Queensland | 4350 | Australia |
| Genesis Cancer Care (previously Premion) | Tugun | Queensland | 4224 | Australia |
| Geelong Hospital | Geelong | Victoria | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| Sir Charles Gairdner | Nedlands | Western Australia | 6009 | Australia |
| D014412 |
| Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |