Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer

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)

Conditions2

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