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

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: 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

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE May 22, 2014
Last Update Posted Date April 20, 2016
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02144727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2014)
  • disease free survival [ Time Frame: 3 year ]
    3 year disease free survival
  • 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
  • Operating time [ Time Frame: op day ]
    Operating time
  • Early postoperative complications [ Time Frame: within 30 days ]
    Early postoperative complications
  • Long term postoperative complications [ Time Frame: after 30 days ]
    Long term postoperative complications
  • 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)
  • Overall cost for the treatment [ Time Frame: operation day to discharge ]
    Overall cost for the treatment (from operative day to discharge day)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
Official Title  ICMJE A Multicenter Randomized Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
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 ).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Adenocarcinoma
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: D2 distal subtotal gastrectomy
  • 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
    Intervention: Procedure: D1+ distal subtotal gastrectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2014)
1880
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Young Woo Kim, Ph.D 82-31-920-1635 gskim@ncc.re.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02144727
Other Study ID Numbers  ICMJE NCCCTS-13-712
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Young-Woo Kim, National Cancer Center, Korea
Study Sponsor  ICMJE National Cancer Center, Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young Woo Kim, PhD National Cancer Center, Korea
PRS Account National Cancer Center, Korea
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP