Comparing two types of lymphadenectomy after chemotherapy for stomach cancer

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

This study is testing whether a more extensive type of surgery for stomach cancer after chemotherapy can help patients do better than the standard surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 539 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Siena (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Siena)
• Trial ID: NCT03961373 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage IIA-IIIC gastric adenocarcinoma who have not received prior treatment.

Not a fit: Patients with distant metastases or those with specific contraindications such as oesophageal invasion or prior treatments for gastric cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with locally advanced gastric cancer.

How similar studies have performed: Previous studies have shown promising results with extended lymphadenectomy approaches, suggesting potential benefits, although this specific comparison is novel.

Eligibility criteria

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 this trial is running

Siena

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

Study contacts

• Principal investigator: Franco Roviello — University of Siena
• Study coordinator: Daniele Marrelli

Conditions Locally Advanced Gastric Cancer