ACTRN12621000991819尚未招募未知
A Feasibility Trial of Patient Derived Cell Culture (PDCC) Chemosensitivity in Head and Neck Carcinoma (HNC)
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 60
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
- •Age equal to 18 years old
- •-Histological or cytological diagnosis of head and neck carcinoma (HNC)
- •-Locally advanced, recurrent or metastatic disease that is thought to have a high probability of treatment failure with standard techniques
- •a.High risk resectable HNC (primary and / or nodal metastases) with sufficient tissue accessible for culture without compromising pathological analysis of the specimen.
- •b.Unresectable HNC (primary or metastatic) with sufficient tissue accessible for culture via open biopsy or core biopsy.
- •-ECOG performance status less than or equal to 2.
- •-Prior systemic therapy is permitted if given more than 6 months prior to study entry in one of the following situations:
- •as neoadjuvant therapy;
- •as part of definitive chemo-radiotherapy for locally advanced disease; or
- •as a component of adjuvant post-surgical treatment.
- •-Adequate haematological function:
- •Hb more than or equal to 90 g/L
- •Platelet count more than or equal to 100
- •Neutrophil count more than or equal to 1.5
- •-Adequate biochemical function
- •Creatinine less than 1.5 times the upper limit of normal
- •AST and / or ALT less than 3 times the upper limit of normal (less than 5 times the upper limit of normal if hepatic metastases present)
- •Bilirubin less than 1.5 times the upper limit of normal (unless known Gilberts disease, in which case less than 3 times the upper limit of normal)
- •-Provision of informed consent.
- •-Female subjects of childbearing potential have a negative pregnancy test at screening and on Day 1 prior to dosing.
- •-Female subjects of childbearing potential who are willing to use a highly effective method of birth control or who are surgically sterile or abstain from heterosexual activity for the course of the study and for 6 months after last dose of systemic anticancer therapy.
排除标准
- •-Prior therapy for recurrent and metastatic head and neck squamous cell carcinoma other than as outlined in the inclusion criteria
- •-Inability to attend for follow up
- •-Presence of a significant comorbidity that would preclude the use of chemotherapy
- •-Known active Hepatitis B or C infection or HIV infection
研究者
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