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

NCT03961373 | Recruiting Phase 3 DMC

• 1 other identifier: Neo-D2plus trial
• Study Type: interventional
• Target: 539
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival analysis

  Overall survival analysis will be analysed during follow up visits

  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 (5)

• Recurrence free-survival

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

• Post-operative morbidity

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

• Post-operative mortality

  Within 30 days from operation or during the hospital stay

• R0 resection

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

• Percentage of completion of protocol treatment

  This outcome measure will be assessed approximately 12 month after the date of enrollment.

Study Arms (2)

Standard Group

ACTIVE COMPARATOR

Neoadjuvant chemotherapy + surgical gastrectomy with D2 lymphadenectomy

Procedure: Gastrectomy with D2 lymphadenectomy

Experimental Group

EXPERIMENTAL

Neoadjuvant chemotherapy + surgical gastrectomy with D2plus lymphadenectomy

Procedure: Gastrectomy with D2plus lymphadenectomy

Interventions

Gastrectomy with D2 lymphadenectomy PROCEDURE

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.

Standard Group

Gastrectomy with D2plus lymphadenectomy PROCEDURE

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

General and Surgical Oncology Department, University of Siena

Siena, 53100, Italy

RECRUITING

MeSH Terms

Interventions

Gastrectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Franco Roviello

  University of Siena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Marrelli

CONTACT

+39577585157; daniele.marrelli@unisi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Clinical Research

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: May 23, 2019
• Study Start: November 5, 2018
• Primary Completion: November 1, 2023
• Study Completion (Estimated): November 1, 2028
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

IT (1)