Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Collection of the R0-Resection rate
研究概览
简要总结
The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant treatment.
This strategy is based upon the clear advantage of perioperative treatment and the fact, that in former trials adjuvant treatment could only be given in half of the patients (Cunningham 2006, Boige 2007).
In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and 5-Fluorouracil (Al-Batran 2008).
Postoperative treatment according to the results of the MAGIC trail is not part of the trail and is given at the responsibility of the participating centres.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically Confirmed Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma (every T, N+ or T3/T4, Nx, M0)
- •Written Informed Consent
- •Age ≥ 18 Years
- •Expected operability
- •Exclusion of Peritoneal Metastasis
- •Adequate Hematological, Renal, Cardiac and Hepatic Function
- •Effective Contraception
排除标准
- •Prior Chemotherapy or Radiotherapy of the Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma
- •Not Histologically Confirmed Primary Tumor
- •Distant Metastasis, Local Relapse
- •Known Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel
- •Known Dihydropyrimidin-Dehydrogenase (DPD) - Deficiency
- •Peripheral Polyneuropathy ≥ Grade II (NCI-CTCAE, Version 3.0)
- •Myocardial Infarction in the last 3 Months, Cardiac Insufficiency Grade II-IV (NYHA)
- •Severe Comorbidity or Acute Infections
- •Pregnancy or Breast Feeding
- •Insufficient Contraception
- •Participation in another Clinical Trial (Simultaneously or 30 Days Prior to Enrollment)
- •Malignancy <5 years (except: Carcinoma In Situ of the Cervix Uteri or Adequately Treated Basalioma of the Skin)
- •Lack of Legal Capacity
研究组 & 干预措施
FLOT
Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
干预措施: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1 (Drug)
FLOT
Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
干预措施: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1 (Drug)
FLOT
Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
干预措施: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1 (Drug)
FLOT
Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
干预措施: 5-FU 2600 mg/m², 24-hour-Infusion, day 1 (Drug)
结局指标
主要结局
Collection of the R0-Resection rate
时间窗: 12 weeks
after 6 cycles of biweekly FLOT chemotherapy and operation.
次要结局
未报告次要终点