Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 539
- 试验地点
- 2
- 主要终点
- Overall survival analysis
研究概览
简要总结
In this study the patients with histological evidence of adenocarcinoma of the stomach will be screened and, if eligible, submitted to neo-adjuvant chemotherapy (NAC). After conclusions of NAC and obtaining informed consent, they will be registered and randomized to receive surgical D2 vs. D2plus lymphadenectomy.
详细描述
This is a prospective multi-centre phase III, two-group, randomized and controlled trial designed to prove superiority of the experimental treatment arm (neo-adjuvant chemotherapy and super-extended lymphadenectomy).
The trial population consists of patients who have histologically confirmed adenocarcinoma of the stomach with locally advanced primary tumour and no evidence of distant metastases (stage IIA-IIIC gastric cancer). The lymph node clinical metastases, before neo-adjuvant chemotherapy, must be limited to the first and second compartments (stations 1-12).
STANDARD GROUP: Neoadjuvant chemotherapy + surgical gastrectomy with D2 lymphadenectomy.
Patients who are assigned to neoadjuvant chemotherapy+ surgical D2 treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2-lymph node dissection is required with specific information about lymph node stations.
EXPERIMENTAL GROUP: Neoadjuvant chemotherapy + surgical gastrectomy with D2plus lymphadenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age equal or greater than 18 years
- •IIA-IIIC histologically proven primary gastric adenocarcinoma, before the treatment with NAC. Not including gastro-oesophageal junction/cardia carcinoma but only Siewert 3, without any previous treatment (surgery and / or chemotherapy) for this diagnosis
- •Lack in CT scan of following:
- •Mediastinal lymph nodes
- •Lung metastases
- •Peritoneal metastases
- •Liver metastases
- •Pleural effusion, ascites
- •Metastases to para-aortic lymph nodes No 16a2/b1
- •Metastases to lymph nodes located in the "posterior" area (8p, 12 b/p, 13)
- •Extra-regional lymph node metastases
- •ECOG performance status ≤ 2
- •No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
- •No oesophageal invasion, or invasion <=3cm
- •Negative peritoneal washing cytology findings and no peritoneal metastases in staging laparoscopy
- •No gastric stump cancer
- •No signs of cervical and subclavear lymph nodes or distal metastases
- •Patient's consent form obtained, signed and dated before beginning specific protocol procedures
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
排除标准
- •Contraindications for any sort of appropriate chemotherapy according to local standards
- •Linitis plastica
- •Second uncontrolled malignant tumour (synchronous or metachronous (last 5 years) other than Cis or mucosal cancer
- •Neoplasms involving the esophago-gastric junction (Siewert types I and II)
- •Expected unresectability after neo-adjuvant treatment or progression in metastases
- •Emergency surgery due to bleeding or perforation
- •Uncontrolled infections
- •Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
- •Pregnant or lactating women
- •Significant neurologic or psychiatric disorders
- •Severe cardiac illness (NYHA class IV)
- •Under treatment of systemic steroids
- •Participation in any other clinical trial that might interfere with the results of this trial
- •Lack of compliance
- •Inability to fill in questionnaires (insufficient command of language, dementia, lack of time)
结局指标
主要结局
Overall survival analysis
时间窗: This outcome measure will be estimated from the time of randomization to the date of death or last follow up visit, assessed approximately 5 years after the disease diagnosis.
Overall survival analysis will be analysed during follow up visits
次要结局
- Percentage of completion of protocol treatment(This outcome measure will be assessed approximately 12 month after the date of enrollment.)
- Post-operative morbidity(This outcome measure will be assessed approximately 3 month after the operation date.)
- R0 resection(This outcome measure will be assessed approximately 3 month after the operation date.)
- Recurrence free-survival(This outcome measure will be estimated from the time of randomization to the date of recurrence, assessed approximately 5 years after the disease diagnosis.)
- Post-operative mortality(Within 30 days from operation or during the hospital stay)
研究者
Franco Roviello
Full Professor, Clinical Research
University of Siena