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Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer (Neo-D2plus)

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ClinicalTrials.gov Identifier: NCT03961373
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Franco Roviello, University of Siena

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.

Condition or disease Intervention/treatment Phase
Locally Advanced Gastric Cancer Procedure: Gastrectomy with D2 lymphadenectomy Procedure: Gastrectomy with D2plus lymphadenectomy Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 539 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standard Versus Super-extended Lymphadenectomy After Neo-adjuvant Chemotherapy for Gastric Cancer
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: Standard Group
Neoadjuvant chemotherapy + surgical gastrectomy with D2 lymphadenectomy
Procedure: Gastrectomy 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.

Experimental: Experimental Group
Neoadjuvant chemotherapy + surgical gastrectomy with D2plus lymphadenectomy
Procedure: Gastrectomy 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.




Primary Outcome Measures :
  1. Overall survival analysis [ 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. ]
    Overall survival analysis will be analysed during follow up visits


Secondary Outcome Measures :
  1. Recurrence free-survival [ 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. ]
    That part will also be analysed during follow up visits. The recurrence has to be documented in radiological, endoscopic or pathological examination, when possible.

  2. Post-operative morbidity [ Time Frame: This outcome measure will be assessed approximately 3 month after the operation date. ]
    Severity of post-operative complications will be analysed using Clavien-Dindo classification

  3. Post-operative mortality [ Time Frame: Within 30 days from operation or during the hospital stay ]
    Deaths after surgery

  4. R0 resection [ Time Frame: This outcome measure will be assessed approximately 3 month after the operation date. ]
    Absence of microscopic (R1) or macroscopic (R2) residual tumor after surgery

  5. Percentage of completion of protocol treatment [ Time Frame: This outcome measure will be assessed approximately 12 month after the date of enrollment. ]
    Percentage of patients who will complete the protocol treatment, including adjuvant chemotherapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Mediastinal lymph nodes
    2. Lung metastases
    3. Peritoneal metastases
    4. Liver metastases
    5. Pleural effusion, ascites
    6. Metastases to para-aortic lymph nodes No 16a2/b1
    7. Metastases to lymph nodes located in the "posterior" area (8p, 12 b/p, 13)
    8. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961373


Contacts
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Contact: Daniele Marrelli +39577585157 daniele.marrelli@unisi.it

Locations
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Italy
General and Surgical Oncology Department, University of Siena Recruiting
Siena, Italy, 53100
Contact: Daniele Marrelli    +39577585157    daniele.marrelli@unisi.it   
Sponsors and Collaborators
University of Siena
Investigators
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Principal Investigator: Franco Roviello University of Siena

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Responsible Party: Franco Roviello, Full Professor, Clinical Research, University of Siena
ClinicalTrials.gov Identifier: NCT03961373     History of Changes
Other Study ID Numbers: Neo-D2plus trial
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases