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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2028
  • participants needed
    539
  • sponsor
    University of Siena
Updated on 23 January 2021

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.

Description

This is a prospective multi-centre phase III, two-group, randomized and controlled trial designed to prove superiority of the experimental treatment arm (neo-adjuvant chemotherapy and super-extended lymphadenectomy).

The trial population consists of patients who have histologically confirmed adenocarcinoma of the stomach with locally advanced primary tumour and no evidence of distant metastases (stage IIA-IIIC gastric cancer). The lymph node clinical metastases, before neo-adjuvant chemotherapy, must be limited to the first and second compartments (stations 1-12).

STANDARD GROUP: Neoadjuvant chemotherapy + surgical gastrectomy with D2 lymphadenectomy.

Patients who are assigned to 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.

EXPERIMENTAL GROUP: Neoadjuvant chemotherapy + surgical gastrectomy with D2plus lymphadenectomy.

Patients who are assigned to neoadjuvant chemotherapy + surgical D2plus 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, 12b/p, 13, 14v, 16a2/b1 is required with specific information about lymph node stations.

In both groups, surgical treatment should be performed within 4-6 weeks after the end of the last cycle of NAC.

The primary objective of this study is to compare overall and cancer-related survival between D2 and D2+ lymphadenectomy following neo-adjuvant chemotherapy for resectable gastric cancer.

In addition, response to chemotherapy, resection rate, quality of life, complications attributable to surgical intervention / side effects of chemotherapy and the duration of hospitalization will be evaluated.

Sample size estimation was performed, to detect the minimum number of patients to be recruited in each arm. A two-sided log rank test with an overall sample size of 539 subjects, of which 270 are in group 1 and 269 are in group 2.

Data will be analyzed using SPSS software. Level of significance will be defined as 5%.

The trial will be open for recruitment from October 2018 to September 2023.

Details
Condition Locally Advanced Gastric Cancer
Treatment Gastrectomy with D2 lymphadenectomy, Gastrectomy with D2plus lymphadenectomy
Clinical Study IdentifierNCT03961373
SponsorUniversity of Siena
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Locally Advanced Gastric Cancer?
Do you have any of these conditions: Do you have Locally Advanced Gastric Cancer??
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
Mediastinal lymph nodes
Lung metastases
Peritoneal metastases
Liver metastases
Pleural effusion, ascites
Metastases to para-aortic lymph nodes No 16a2/b1
Metastases to lymph nodes located in the "posterior" area (8p, 12 b/p, 13)
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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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