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A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer (ADDICT)

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ClinicalTrials.gov Identifier: NCT02144727
Recruitment Status : Recruiting
First Posted : May 22, 2014
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Young-Woo Kim, National Cancer Center, Korea

Brief Summary:
In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ).

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Procedure: D2 distal subtotal gastrectomy Procedure: D1+ distal subtotal gastrectomy Phase 3

Detailed Description:

■ Background of Hypothesis A. JCOG (Japanese Clinical Oncology Group) 9501 Study

: Addition of aorta lymph node dissection to D2 lymph node dissection does not increase survival rate.

Wide range of operation is not always the best treatment. If invasion rate can be kept as minimal as possible while maintaining survival rate, it can lead to more secure operation while also reducing the frequency of complication after the surgery. 20 It may be advantageous for patients in terms of operation time, cost, and quality of life.

B. COACT 1001 study A previous study which compared the feasibility of lymph node dissection in open surgery and lapraroscopic surgery for advanced gastric cancer.

11p, 12a lymph node (D2) resection rate: 79.2% and 88.8% respectively in all advance gastric cancer.

11p, 12a lymph node (D2) metastasis rate: 1.9% and 2.9% respectively. Subgroup analysis 11p, 12a lymph node resection in cStage IB/IIA: 74.5-80.0% and 86.7-96.1% respectively. : 0% metastasis rate for both.

lymph node dissection in cStage IIB/IIIA: 81.1-82.3% and 87.5-89.2% respectively.: metastasis rates are 2.1% and 2.4-12.1% respectively.

Application: 11p and 12a lymph nodes, which belong in D2 lymph nodes, need to be resected in advance gastric cancer in IIB stage or higher. However, in earlier stages of advance gastric cancer, the probability of metastasis is very low; therefore, resection of D1+ lymph nodes, excluding 11p and 12a, is enough.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: D2 distal subtotal gastrectomy
D2 distal subtotal gastrectomy D2 includes Nos.1.3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
Procedure: D2 distal subtotal gastrectomy
D2 includes Nos.1.3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.

Experimental: D1+ distal subtotal gastrectomy
D1+ distal subtotal gastrectomy D1+ includes Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
Procedure: D1+ distal subtotal gastrectomy
D1+ includes Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]
    To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B & II advanced gastric cancer


Secondary Outcome Measures :
  1. disease free survival [ Time Frame: 3 year ]
    3 year disease free survival

  2. Subgroup analysis of Laparoscopic surgery versus open surgery [ Time Frame: 3 year , 5 year ]
    Subgroup analysis of Laparoscopic surgery versus open surgery in terms of 3 year relapse free survival and 5 year overall survival

  3. Operating time [ Time Frame: op day ]
    Operating time

  4. Early postoperative complications [ Time Frame: within 30 days ]
    Early postoperative complications

  5. Long term postoperative complications [ Time Frame: after 30 days ]
    Long term postoperative complications

  6. Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D) [ Time Frame: baseline, 1 week, 1month, 6 month, 1 year, 3 year ]
    Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)

  7. Overall cost for the treatment [ Time Frame: operation day to discharge ]
    Overall cost for the treatment (from operative day to discharge day)

  8. Finding biomarkers predicting lymph node metastasis and recurrence [ Time Frame: 3 year ]
    Finding biomarkers predicting lymph node metastasis and recurrence for prediction of lymph node metastasis and recurrence



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • Histologically proven primary gastric adenocarcinoma
  • T1N1, T2N0, T2N1, T3N0, T3N1 by CT scan (AJCC 7th classification) and intraoperative surgical staging prior to resectional procedure
  • Location of primary tumor; antrum, or angle, lower body or mid body of the stomach
  • No evidence of other distant metastasis
  • Aged ≥ 20 year old
  • Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
  • No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
  • Adequate organ functions defined as indicated below:

    • WBC 3000/mm3 - 12,000/mm3
    • >serum Hemoglobin 8.0 g/dl
    • > serum Platelet 100 000/mm3
    • < serum AST 100 IU/l
    • <serum ALT 100 IU/l
    • < Total Bilirubin 2.0 mg/dl
  • Written signed informed consent

Exclusion Criteria :

  • Active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
  • Gastric remnant cancer
  • ≥T4a in surgical staging before resection
  • N2 or more (number of metastatic lymph nodes ≥3) in CT scan
  • Histologically rare variants in WHO Classification such as Adenosquamous, Hepatoid, Squamous cell, Undifferentiated, , neuroendocrine carcinoma and others
  • Pregnant or breast-feeding women
  • Mental disorder(diagnosed with mental disorder on medical record)
  • systemic administration of corticosteroids(include Herbal Medication)
  • unstable angina or myocardial infarction within 6 months of the trial
  • unstable hypertension
  • severe respiratory disease requiring continuous oxygen therapy
  • previous upper abdominal surgery except laparoscopic cholecystectomy

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): NCT02144727


Contacts
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Contact: Young Woo Kim, Ph.D 82-31-920-1635 gskim@ncc.re.kr

Locations
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Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Young Woo Kim, PhD National Cancer Center, Korea

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Responsible Party: Young-Woo Kim, Head of Gastric Cancer Branch, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02144727    
Other Study ID Numbers: NCCCTS-13-712
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms