Comparing two types of lymphadenectomy after chemotherapy for stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial aims to evaluate the effectiveness of super-extended lymphadenectomy compared to standard D2 lymphadenectomy in patients with locally advanced gastric cancer who have undergone neo-adjuvant chemotherapy. Eligible patients will be randomized into two groups: one receiving standard D2 lymphadenectomy and the other receiving the experimental D2plus lymphadenectomy, which includes additional lymph node resections. The study will assess the surgical outcomes and potential benefits of the extended procedure in improving patient prognosis. The trial is being conducted at the University of Siena and involves multiple centers.

Why it matters

Who can join: the full rules

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)

Where it's running

• General and Surgical Oncology Department, University of Siena
  Siena, Italy Recruiting

Study contacts

• Principal investigator: Franco Roviello — University of Siena
• Study coordinator: Daniele Marrelli
• Email: daniele.marrelli@unisi.it
• Phone: +39577585157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.