Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Determination of progression-free survival after 2 years
研究概览
简要总结
A combination therapy of Docetaxel, Cisplatin und 5-Fluorouracil (= TPF) will be used in patients with resectable oropharyngeal and cavity of the mouth cancer. To improve the compatibility of the TPF-induction without decreasing the efficacy the dose will be given on day 1 and 8 instead of applying the whole dose on day 1 every 3 weeks.
In the phase I-part of the trial the optimal therapeutic dose of Docetaxel and Cisplatin will be defined.
In the phase II-part the progression-free survival after 2 years will be assessed in patients treated with the optimal therapeutic dose.
详细描述
Local advanced Oropharyngeal and cavity of the mouth Cancer are often treated with a combination of surgery and/or radiation and /or chemotherapy.
Despite of therapy improvement there are only little advances in progression-free survival and overall survival.
Therefore new therapy concepts are needed. The advantage of the induction chemotherapy is the possibility of tumor response assessment during chemotherapy and may present a selection criterion for organ preservation.
In order to minimize the time between chemotherapy and surgery it is important to have an early answer for the tumor response. In this study response will be assessed after the first cycle of chemotherapy. Patients showing no tumor response will be operated at once. The other patients will receive further cycles of chemotherapy.
Toxicity of the induction chemotherapy have to be moderate because surgery should not be delayed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological proven, resectable squamous epithelial carcinoma of the oropharynx and the cavity of the mouth
- •R0-resection possible
- •All T N2 M0 / all T N3 M0 / if T3 or T4a also N0-1 M0
- •Leucocytes > 4000/mm³ bzw. neutrophils > 2000/mm³, thrombocytes > 100000/mm³
- •adequate kidney function, defined as serum creatinine und urea in normal range, Creatinine clearance > 60 ml/min
- •adequate liver function with glutamate oxaloacetate transaminase (SGOT), glutamate pyruvate transaminase (SGPT) and bilirubin in normal range
- •electrolytes in normal range
- •risks of anesthesia complications normal or minor increased
- •Eastern Cooperative Oncology Group (ECOG) 0-2 / Karnofsky >= 60%
- •Age 18 - 80 years
- •signed written informed consent
- •effective contraception for both male and female subjects if the risk of conception exists
排除标准
- •T1 N0 M0 / T1 N1 M0 / T2 N0 M0 / T2 N1 M0
- •Resection without curative intention: primary tumor is not treatable with resection methods
- •Infiltration of the lower jaw
- •Tumor not measurable with Innovation Center Computer Assisted Surgery (ICCAS) methods
- •No prior chemotherapy or radiation (a primary surgery is allowed)
- •Metachronous or oder synchronous malignoma (Exception: basal cell carcinoma)
- •Life expectance < 3 months
- •ECOG > 2; Karnofsky < 60%
- •acute infections or fever
- •known HIV-infection or other immune suppression
- •severe cardio pulmonary concomitant diseases
- •chronic disease with continuous therapy (uncontrolled diabetes, rheumatoid arthritis) especially continuous therapy with steroids
- •other concomitant diseases which, in the investigator's opinion, would exclude the patient from the study
- •Contraindications which permit a therapy with Docetaxel, Cisplatin, 5-FU or radiation therapy
- •missing patient's compliance
- •regular Follow-up visits not possible
- •Pregnancy or lactation period
- •legal incapacity or limited legal capacity
- •Participation in another clinical trial or administration of a not approved substance within 30 days before registration
研究组 & 干预措施
Taxotere, Cisplatin, 5-Fluorouracil (5-FU)
Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out.
干预措施: Taxotere, Cisplatin, 5-Fluorouracil (5-FU) (Drug)
结局指标
主要结局
Determination of progression-free survival after 2 years
时间窗: 24 months
次要结局
- Overall survival after 2 years(after 2 years)
- Quality of life(0,1, 6, 12, 18, 24 months)
- Determination of the efficacy of the induction therapy(after 1, 12 and 24 months)
- Function of swallowing according the penetration-aspiration-scale(0,1, 6, 12, 18, 24 months)
- Adverse events as a measure of safety and tolerability(once a week)
研究者
Orlando Guntinas-Lichius, Prof. Dr. med.
Professor Dr. med.
University of Jena