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

ConditionLocally Advanced Gastric Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Siena

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Mediastinal lymph nodes

Lung metastases

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gastrectomy with D2 lymphadenectomy

    Procedure/Surgery

    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.

  • Gastrectomy with D2plus lymphadenectomy

    Procedure/Surgery

    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.

Treatment groups

539 Participants
are divided into 2 treatment groups
Group A: Standard GroupActive comparator 1 intervention
Group B: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival analysis

Overall survival analysis will be analysed during follow up visits

Time frame
This outcome measure will be estimated from the time of randomization to the date of death or last follow up visit, assessed approximately 5 years after the disease diagnosis.

Secondary outcomes

1

Recurrence free-survival

That part will also be analysed during follow up visits. The recurrence has to be documented in radiological, endoscopic or pathological examination, when possible.

Time frame
This outcome measure will be estimated from the time of randomization to the date of recurrence, assessed approximately 5 years after the disease diagnosis.
2

Post-operative morbidity

Severity of post-operative complications will be analysed using Clavien-Dindo classification

Time frame
This outcome measure will be assessed approximately 3 month after the operation date.
3

Post-operative mortality

Deaths after surgery

Time frame
Within 30 days from operation or during the hospital stay
4

R0 resection

Absence of microscopic (R1) or macroscopic (R2) residual tumor after surgery

Time frame
This outcome measure will be assessed approximately 3 month after the operation date.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Siena

Lead sponsor

Source ClinicalTrials.gov
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