RecruitingPhase 3NCT03961373

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

Sponsor

University of Siena

Enrollment

539 participants

Start Date

Nov 5, 2018

Study Type

INTERVENTIONAL

Conditions

Locally Advanced 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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of lymph node removal surgery for stomach cancer that has been treated with chemotherapy before surgery (called neoadjuvant chemotherapy). One approach removes the standard number of lymph nodes, while the other removes a larger extended area. Researchers want to find out if removing more lymph nodes improves survival. **You may be eligible if...** - You are at least 18 years old - You have stage IIA–IIIC primary stomach adenocarcinoma confirmed by biopsy - You have received neoadjuvant (pre-surgical) chemotherapy - You have not had prior stomach surgery or chemotherapy for this cancer before the neoadjuvant treatment - The tumor is in the stomach proper (not at the junction with the esophagus, except for Siewert type 3) **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have had prior stomach or upper abdominal surgery - You are not fit for major surgery - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREGastrectomy 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.

PROCEDUREGastrectomy 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.

Locations(1)

General and Surgical Oncology Department, University of Siena

Siena, Italy

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NCT03961373

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