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"Phase III Randomized Trial Comparing D2 vs D3 Lymphadenectomy With Gastric Cancer Following Neoadjuvant Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139605
Recruitment Status : Recruiting
First Posted : May 15, 2014
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Shailesh Vinayak Shrikhande, Tata Memorial Centre

Study Description
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Brief Summary:

Stomach cancer is the second most common cause of cancer-related deaths in India. Curative surgery offers the only chance of improving survival in this cancer. In patients whose cancer has not spread to other parts of the body (beyond the stomach and lymph nodes around it), removal of stomach (gastrectomy) with lymph nodes around the stomach and along the major vessels supplying blood to the stomach (D2 lymphadenectomy) is regarded as current standard of care at Tata Memorial Centre. However, the extent of lymphadenectomy is controversial. Some studies have suggested that removing more lymph nodes, even around the major vessels of the abdomen (aorta and inferior vena cava) may not only help to accurately determine the disease spread, but may also confer an additional survival benefit. Removing more lymph nodes around the major vessels may increase the risk of morbidity to the patient.

In the last 5-6 years, stomach cancer specialists around the world have resorted to giving half the cycles of chemotherapy to the patient before the surgery (neoadjuvant chemotherapy), and the other half after the surgery in what is called 'perioperative chemotherapy'. This has been shown to lead to more patients surviving to 5 years, than before.

The investigators feel that perioperative chemotherapy with D2 lymphadenectomy may constitute the best care for our patients with stomach cancer such that no further removal of lymph nodes beyond is required. However, the investigators have no evidence in literature to support this hypothesis. The investigators have thus designed this trial based on which we propose that there exists no difference between a D2 lymphadenectomy and a D3 lymphadenectomy following neoadjuvant chemotherapy for non-metastatic, locally advanced but resectable gastric cancer. The data will enable the development of clear management guidelines for lymph node dissection in stomach cancer.


Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: D3 Lymphadenectomy Not Applicable

Detailed Description:

The only data comparing D2 and D3 comes from a multi-institutional, non-randomised study which reported that D3 lymphadenectomy conferred a survival advantage over D2 in tumours that were 50-100mm in diameter, with or without lymph nodal disease.

Of the three published randomised controlled trials(RCT) comparing D2 versus D2+paraaortic nodal dissection (PAND), two of the studies in which the long-term results are available, were carried out in Japan. In both these studies, the patients were not offered chemotherapy until after they developed a recurrence. Another reason is the benefit on survival, albeit modest, in patients undergoing D3 lymphadenectomy that has been noted in the study by Wu et al.

Another important reason for comparing D2 versus D2+PAND, lies in the fact that none of the aforementioned RCTs have been performed after the 1998 revision in the definition of lymph node stations by the Japanese Gastric cancer association. Hence, none of these results can be considered representative of the current classifications.

Duly considering the possible higher morbidity that has been shown with a complete para aortic lymph node dissection, the investigators propose to study a more extensive lymphadenectomy than D2 but without increasing the risk of morbidity in the patient.

D2 lymphadenectomy has been performed at Tata Memorial Centre (TMC), since 2002 with morbidity and mortality rates comparable to world literature It is the standard form of lymphadenectomy in TMC. Hence, the trial will be performed by surgeons experienced in the technique. D3 is performed in some centres in Japan, Italy and Taiwan (where the only randomized controlled trial demonstrated a survival benefit of D3 over D1). Both the procedures are well established and regarded as standards in different parts of the world.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Gastrectomy with D2 or D3 lymphadenectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Controlled Trial Comparing D2 Versus D3 Lymphadenectomy on Outcomes of Non-metastatic, Resectable, But Locally Advanced, Gastric Cancer Following Neoadjuvant (Perioperative) Chemotherapy (ELANCe Trial)
Study Start Date : August 2013
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: D2 Lymphadenectomy
Intervention D3 Lymphadenectomy
 Procedure: D3 Lymphadenectomy
D3 Lymphadenectomy involves surgical removal of lymph nodes from echelon or compartments 1 to 3 in gastric cancer patients
Experimental: D3 Lymphadenectomy
Comparator D2 Lymphadenectomy
 Procedure: D3 Lymphadenectomy
D3 Lymphadenectomy involves surgical removal of lymph nodes from echelon or compartments 1 to 3 in gastric cancer patients


Outcome Measures
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Primary Outcome Measures :
  1. primary endpoint:Overall Survival [ Time Frame: 5 year ]
    overall survival will be calculated from randomization to death.


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 2 year ]
    Disease-free survival will be calculated from definitive resection to the first event (i.e., local recurrence, distant recurrence, or death from any cause


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG performance status of 0 - 1 in patients deemed fit to undergo surgery at the pre-anaesthetic check
  • Histologically proven gastric adenocarcinoma
  • No evidence of distant metastases, or locally advanced inoperable disease, as evaluated by computed tomography, chest radiography, ultrasonography, and / or laparotomy
  • Patient able to provide valid informed consent
  • Patient completed at least 1 cycle of neoadjuvant chemotherapy

Exclusion Criteria:

  • Presence of any 1 of the following:
  • Previous or concomitant other cancer
  • Primary Oesophageal involvement extending to the stomach
  • Distant hepatic / extrahepatic disease discovered on laparotomy
  • Gross local disease in the porta precluding a curative resection
  • Patient did not consent for the trial
Contacts and Locations
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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): NCT02139605


Contacts
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Contact: Dr Shailesh V Shrikhande, MBBS MS MD +91 222417 7000 ext 7173 shailushrikhande@hotmail.com
Contact: Dr Ashwin Luis Desouza, MBBS MS +91 222417 7000 ext 6329 ashwindesouza@gmail.com

Locations
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India
Dr Shailesh Vinayak Shrikhande Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Dr Shailesh v Shrikhande, MBBS MS MD    +91 22 2417 7000 ext 7173    shailushrikhande@hotmail.com   
Contact: Dr Bhawna Sirohi, MBBS DCH    +91 22 2417 7000 ext 6755    bhawna.Sirohi13@gmail.com   
Principal Investigator: Dr Shailesh V Shrikhande, MBBS MS MD         
Sub-Investigator: Dr.Ashwin L Desouza, MBBS MS         
Sub-Investigator: Dr Mukta Ramadwar, MBBS MD MRC         
Sub-Investigator: Dr Mahesh Goel, MBBS MS         
Sub-Investigator: Dr Shaesta Mehta, MBBS DNB MD         
Sub-Investigator: Dr Nitin shetty S Shetty, MBBS MD DNB         
Sub-Investigator: Dr Supreeta Arya, MD DNB DMRD         
Sub-Investigator: Dr Keadar Deodhar, MBBS MD MRC         
Sub-Investigator: Dr Munita Bal, MBBS MD DNB         
Sub-Investigator: Dr.Shraddha Patkar, MBBS MS         
Sub-Investigator: Dr.Abhishek Mitra, MBBS MS         
Sponsors and Collaborators
Tata Memorial Centre
Investigators
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Principal Investigator: Dr Shailesh V Shrikhande, MBBS MS MD Tata Memorial Centre
More Information
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Responsible Party: Dr Shailesh Vinayak Shrikhande, Professor and GI HPB Surgeon, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT02139605    
Other Study ID Numbers: 87
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: data of patient kept confidential
Keywords provided by Dr Shailesh Vinayak Shrikhande, Tata Memorial Centre:
D2 versus D3 Lymphadenectomy
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