None listed
Conditions
Brief summary
The overall objective of this study is to develop a well tolerated chemo-radiotherapy regimen for patients with Merkel Cell Carcinoma (MCC) of the skin that achieves high rates of control. You may be eligible to join this study if you are aged 18 or over and have been diagnosed with stage II or stage III Merkel Cell Carcinoma of the skin with no evidence of distant spread. All participants in this study will undergo radiation therapy for 5 days per week for 5 weeks whilst being administered Carboplatin intravenously (i.e. directly into the vein) once per week. Three weeks after the end of radiation therapy, patients will commence 3 x 3-week cycles of intravenous Carboplatin, administered on day 1 of each cycle, and intravenous Etoposide, administered on days 1-3 of each cycle. Patients will be assessed by PET scan, CT and/or bone scan, and monitored for therapy side effects and survival every 3-6 months for 5 years. The PET scans will be used to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment. It is hoped that the findings of this trial will lead to a greater understanding of the effect and toxicity of Carboplatin-Etoposide chemotherapy in combination with radiation therapy for stage II and III Merkel Cell Carcinoma.
Interventions
Arm A: Experimental. Treatment: drugs - Carboplatin. During Radiotherapy: Carboplatin (dose calculated using Calvert formula with Area Under the Curve (AUC) 2.0) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation). Carboplatin is administered intravenously over 20-30 minutes.
After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (dose calculated using Calvert formula using AUC4.5) intravenously on day 1
Arm A: Experimental. Treatment: drugs - Carboplatin. During Radiotherapy: Carboplatin (dose calculated using Calvert formula with Area Under the Curve (AUC) 2.0) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation). Carboplatin is administered intravenously over 20-30 minutes. After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (dose calculated using Calvert formula using AUC4.5) intravenously on day 1. Treatment: drugs - Etoposide. After radiotherapy: 3 weeks after completion of radiotherapy, 3 cycles of 3 weekly etoposide (80mg/m2/day), given intravenously days 1-3. Treatment: other - Radiotherapy. Micrscopic Disease: 50 Gy in 2Gy doses over 25 fractions (5 weeks). Macroscopic Disease: 54 Gy in 2Gy doses over 27 fractions (5 1/2 weeks).
Sponsors
Trans Tasman Radiation Oncology Group (TROG)
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients may be included in 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-Fluoro Deoxy Clucose (FDG) PET scan (no uncontrolled diabetes mellitus or severe claustrophobia). · Available for follow-up. · Using adequate contraception if capable of child bearing · High risk disease with no evidence of distant spread: Biopsy proven Merkel Cell Carcinoma (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 · Eastern Cooperative Oncology Group (ECOG) 0-2. · Full Blood Count (FBC) should be satisfactory ( Haemoglobin > 10g/dl, neutrophils > 2.0 x 109 /l and platelets > 100 x 109 /l) and renal function (Glomerular Filtration Rate (GFR) > 50 ml/min) and hepatic function (Alanine aminotransferase (ALT) < 5 X upper limit normal, bilirubin < 1.5 X upper limit normal) · No evidence of metastases on CT staging; OR If CT is suggestive of multiple metastases, they must be PET negative. · No evidence of other malignancy in the past 5 years other than non-melanoma skin cancer
Exclusion criteria
Patients who fulfil any of the following criteria are not eligible for admission to the trial: · 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. · Chest CT showing multiple nodules greater than 10mm which are PET positive. · Any serious illness or medical condition that precludes the safe administration of the chemotherapy including: (a) Active infection (b) Uncontrolled or unstable cardiac disease including unstable angina, myocardial infarction within the last 3 months, and recurrent ventricular arrhythmias
Outcome results
None listed