Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT03961373

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

Led by University of Siena · Updated on 2019-05-23

539

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed stage IIA to IIIC primary gastric adenocarcinoma before neo-adjuvant chemotherapy
  • Tumor not involving gastro-esophageal junction/cardia carcinoma except Siewert 3
  • No prior surgery or chemotherapy for this cancer diagnosis
  • No evidence on CT scan of mediastinal lymph nodes, lung, peritoneal, liver metastases, pleural effusion, ascites, para-aortic lymph node metastases, posterior lymph node metastases (stations 8p, 12b/p, 13), or extra-regional lymph node metastases
  • ECOG performance status of 2 or less
  • No prior radio- or chemotherapy conflicting with gastric cancer treatment
  • No oesophageal invasion greater than 3 cm
  • Negative peritoneal washing cytology and no peritoneal metastases on staging laparoscopy
  • No gastric stump cancer
  • No signs of cervical, supraclavicular lymph nodes, or distant metastases
  • Signed informed consent before protocol procedures
  • No psychological, familial, sociological, or geographical issues that could prevent compliance with the study and follow-up
Not Eligible

You will not qualify if you...

  • Contraindications to appropriate chemotherapy per local standards
  • Diagnosis of linitis plastica
  • Presence of uncontrolled second malignant tumor in last 5 years except certain skin or mucosal cancers
  • Tumors involving esophago-gastric junction Siewert types I and II
  • Expected unresectability or progression to metastases after neo-adjuvant treatment
  • Emergency surgery due to bleeding or perforation
  • Uncontrolled infections
  • Serious medical conditions that impair study participation
  • Pregnancy or lactation
  • Significant neurological or psychiatric disorders
  • Severe cardiac illness (NYHA class IV)
  • Current treatment with systemic steroids
  • Participation in another clinical trial interfering with this study
  • Lack of compliance
  • Inability to complete questionnaires due to language, dementia, or time constraints

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

General and Surgical Oncology Department, University of Siena

Siena, Italy, 53100

Actively Recruiting

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Research Team

D

Daniele Marrelli

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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