Recruiting
Phase 3
Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
Condition(s) studied
Locally Advanced Gastric Cancer
Investigational drug(s) / intervention(s)
Gastrectomy with D2 lymphadenectomyGastrectomy with D2plus lymphadenectomy
Gastrectomy with D2 lymphadenectomy: Patients who are assigned to the 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.
Gastrectomy with D2plus lymphadenectomy: Patients who are assigned to the neoadjuvant chemotherapy + surgical D2+ extended lymphadenectomy treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2+ lymph node dissection plus resection of stations 8p, 12p, 13, 14v, 16a2/b1 is required with specific information about lymph node stations.
Study summary
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.
Eligibility
Inclusion Criteria:
* 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:
1. Mediastinal lymph nodes
2. Lung metastases
3. Peritoneal metastases
4. Liver metastases
5. Pleural effusion, ascites
6. Metastases to para-aortic lymph nodes No 16a2/b1
7. Metastases to lymph nodes located in the "posterior" area (8p, 12 b/p, 13)
8. 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
Exclusion Criteria:
* 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)
Primary outcome measure(s)
- Overall survival analysis — 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
Trial sites (1)
| Facility | City | Region | Status |
|---|
| General and Surgical Oncology Department, University of Siena |
Siena |
Italy |
Recruiting |
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