ACTRN12610000480088进行中（未招募）2 期
Trans Tasman Radiation Oncology Group (TROG) 09.03 - A Phase II Efficacy Study of Chemo-Radiotherapy in Positron Emission Tomography (PET) Stage II and III Merkel Cell Carcinoma of the Skin
Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 50 人开始时间: 2010年6月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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