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

April 18, 2016 updated by: Young-Woo Kim, National Cancer Center, Korea

A Multicenter Randomized Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

1880

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-702
        • Not yet recruiting
        • Kosin University Gospel Hospital
        • Contact:
        • Sub-Investigator:
          • Kyung Won Seo, Dr
        • Sub-Investigator:
          • Ki Young Yoon, Dr
        • Principal Investigator:
          • Sang Ho Lee, Dr
      • Busan, Korea, Republic of, 602-739
        • Not yet recruiting
        • Pusan National University Hospital
        • Contact:
        • Sub-Investigator:
          • Dae Hwan Kim, Dr
        • Principal Investigator:
          • Dong Heon Kim, Dr
      • Busan, Korea, Republic of, 602-812
        • Not yet recruiting
        • Dong-A University Hospital
        • Contact:
          • Ki-Han Kim, Dr
          • Phone Number: +82-51-240-2643
        • Principal Investigator:
          • Ki-Han Kim, Dr
        • Sub-Investigator:
          • Min Chan Kim, Dr
      • Busan, Korea, Republic of, 619-953
        • Not yet recruiting
        • Dongnam Inst. of Radiological & Medical Sciences
        • Contact:
        • Principal Investigator:
          • Jae-Seok Min, Dr
      • Busan, Korea, Republic of, Busan 612-896
        • Not yet recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
        • Principal Investigator:
          • Byoung-Jo Suh, Dr
        • Sub-Investigator:
          • Sung-Jin Oh, Dr
      • Daegu, Korea, Republic of, 700-721
        • Not yet recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Ho Young Chung, Dr
          • Phone Number: +82-53-200-5601
        • Principal Investigator:
          • Ho Young Chung, Dr
      • Daegu, Korea, Republic of, 700-712
        • Not yet recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
        • Principal Investigator:
          • Seung Wan Ryu, Dr
        • Sub-Investigator:
          • Young Gil Son, Dr
      • Daegu, Korea, Republic of, 702-210
        • Not yet recruiting
        • Kungpook National University Hospital
        • Contact:
          • Wansik Yu, Dr
          • Phone Number: +82-10-9069-0365
          • Email: wyu@knu.ac.kr
        • Sub-Investigator:
          • O Kyoung Kwon, Dr
        • Principal Investigator:
          • Wansik Yu, Dr
      • Daegu, Korea, Republic of, 704-802
        • Not yet recruiting
        • Daegu Veterans Hospital
        • Contact:
        • Principal Investigator:
          • Taebong Kim, Dr
      • Daegu, Korea, Republic of, 705-703
        • Not yet recruiting
        • Yeungnam University Medical Center
        • Contact:
        • Principal Investigator:
          • Se Won Kim, Dr
      • Daegu, Korea, Republic of, 705-718
        • Not yet recruiting
        • Daegu Catholic Univ. Medical Center
        • Contact:
        • Principal Investigator:
          • Hyun Dong Chae, Dr
      • Daejeon, Korea, Republic of, 301-721
        • Not yet recruiting
        • Chungnam National University Hospital
        • Contact:
          • Ji Young Sul, Dr
          • Phone Number: +82-10-5420-8369
          • Email: jsul@cnu.ac.kr
        • Principal Investigator:
          • Ji Young Sul, Dr
      • Incheon, Korea, Republic of, 400-711
        • Not yet recruiting
        • Inha University Hospital
        • Contact:
        • Principal Investigator:
          • Yoon Seok Heo, Dr
      • Incheon, Korea, Republic of, 403-720
        • Not yet recruiting
        • The Catholic University of Korea Incheon St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Jin-Jo Kim, Dr
        • Sub-Investigator:
          • Jung Sun Lee, Dr
        • Sub-Investigator:
          • Chang-Hyun Kim, Dr
      • Incheon, Korea, Republic of, 405-760
        • Not yet recruiting
        • Gachon University Gill Medical Center
        • Contact:
        • Principal Investigator:
          • Woon Ki Lee, Dr
      • Seoul, Korea, Republic of, 135-710
        • Not yet recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Jae-Moon Bae, Ph.D
        • Sub-Investigator:
          • Sang-Hyun Kim, Dr
        • Sub-Investigator:
          • Jun Ho Lee, Dr
      • Seoul, Korea, Republic of, 130-872
        • Not yet recruiting
        • KyungHee University Medical Center
        • Contact:
        • Principal Investigator:
          • Yong Ho Kim, Dr
      • Seoul, Korea, Republic of, 110-744
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
        • Sub-Investigator:
          • Seong-Ho Kong, Dr
        • Sub-Investigator:
          • Yun-Suhk Suh, Dr
        • Principal Investigator:
          • Han-Kwang Yang, Dr
        • Sub-Investigator:
          • Hyuk-Joon Lee, Dr
      • Seoul, Korea, Republic of, 110-747
        • Not yet recruiting
        • Seoul Red Cross Hospital
        • Contact:
        • Principal Investigator:
          • Dong Gue Shin, Dr
      • Seoul, Korea, Republic of, 120-752
        • Not yet recruiting
        • Severance Hospital
        • Contact:
          • Woo-Jin Hyung, Dr
          • Phone Number: +82-2-2228-5170
        • Sub-Investigator:
          • In Kyu Kwon, Dr
        • Sub-Investigator:
          • Jong Won Kim, Dr
        • Sub-Investigator:
          • Hyung Il Kim, Dr
        • Sub-Investigator:
          • Sung Hoon Noh, Dr
        • Sub-Investigator:
          • Hyun-Baek Shin, Dr
        • Sub-Investigator:
          • Ji-Young Ahn, Dr
        • Sub-Investigator:
          • In Cho, Dr
        • Principal Investigator:
          • Woo-Jin Hyung, Dr
      • Seoul, Korea, Republic of, 133-792
        • Not yet recruiting
        • Hanyang University Medical Center
        • Contact:
        • Principal Investigator:
          • Sung Joon Kwon, Dr
      • Seoul, Korea, Republic of, 134-727
        • Not yet recruiting
        • Kyung Hee University Hospital at Gangdong
        • Contact:
        • Principal Investigator:
          • Sung Il Choi, Dr
      • Seoul, Korea, Republic of, 134-791
        • Not yet recruiting
        • VHS Medical Center
        • Contact:
          • Ho-Geun Yoon, Dr
          • Phone Number: +82-2-2225-1234
        • Principal Investigator:
          • Ho-Geun Yoon, Dr
      • Seoul, Korea, Republic of, 135-720
        • Not yet recruiting
        • Gangnam Severance Hospital
        • Contact:
        • Principal Investigator:
          • Seung-Ho Choi, Dr
      • Seoul, Korea, Republic of, 136-705
        • Not yet recruiting
        • Korea University Anam Hospital
        • Contact:
        • Principal Investigator:
          • Sung Heum Park, Dr
      • Seoul, Korea, Republic of, 137-701
        • Not yet recruiting
        • The Catholic University of Korea St. Mary's Hospital
        • Contact:
        • Sub-Investigator:
          • Kyo-Young Song, Dr
        • Principal Investigator:
          • Hae Myung Jeon, Dr
      • Seoul, Korea, Republic of, 138-736
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
        • Sub-Investigator:
          • Byung-Sik Kim, Dr
        • Sub-Investigator:
          • Moon-Won Yoo, Dr
        • Principal Investigator:
          • Jeong-Hwan Yook, Dr
      • Seoul, Korea, Republic of, 139-709
        • Not yet recruiting
        • Korea Cancer Center Hospital
        • Contact:
        • Principal Investigator:
          • Hang Jong Yu, Dr
        • Sub-Investigator:
          • Jong In Lee, Dr
        • Sub-Investigator:
          • Sung Ho Jin, Dr
      • Seoul, Korea, Republic of, 140-887
        • Not yet recruiting
        • Soon Chun Hyang University Hospital Seoul
        • Contact:
        • Principal Investigator:
          • Yong Jin Kim, Dr
        • Sub-Investigator:
          • Ji Yeon Park, Dr
      • Seoul, Korea, Republic of, 143-729
        • Not yet recruiting
        • Konkuk University Medical Center
        • Contact:
        • Principal Investigator:
          • Ho-Yoon Bang, Dr
        • Sub-Investigator:
          • Pyoung Su Kim, Dr
      • Seoul, Korea, Republic of, 150-037
        • Not yet recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Sub-Investigator:
          • Dae Hyun Yang, Dr
        • Sub-Investigator:
          • Hae Wan Lee, Dr
        • Principal Investigator:
          • Man Sup Lim, Dr
        • Sub-Investigator:
          • Ji Woong Cho, Dr
      • Seoul, Korea, Republic of, 152-703
        • Not yet recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Young Jae Mok, Dr
        • Sub-Investigator:
          • You Jin Jang, Dr
      • Seoul, Korea, Republic of, 156-707
        • Not yet recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
          • Hye Sung Ahn, Dr
          • Phone Number: +82-2-2072-3797
        • Principal Investigator:
          • Hye Sung Ahn, Dr
      • Seoul, Korea, Republic of, 156-755
        • Not yet recruiting
        • Chung-Ang University Hospital
        • Contact:
        • Sub-Investigator:
          • Joong-Min Park, Dr
        • Principal Investigator:
          • Kyeung Chun Chi, Dr
      • Seoul, Korea, Republic of, 158-710
        • Not yet recruiting
        • Ewha Womans University Medical Center
        • Contact:
        • Sub-Investigator:
          • Yong Il Kim, Dr
        • Principal Investigator:
          • Joo Ho Lee, Dr
    • Chuncheongnam-Do
      • Cheonan, Chuncheongnam-Do, Korea, Republic of, 330-721
        • Not yet recruiting
        • Soon Chun Hyang University Hospital Cheonan
        • Contact:
          • Moon Soo Lee, Dr
          • Phone Number: +82-41-570-2114
        • Principal Investigator:
          • Moon Soo Lee, Dr
    • Daejon
      • Metropolitan City Daejon, Daejon, Korea, Republic of, 302-718
        • Not yet recruiting
        • Konyang University Hospital
        • Contact:
        • Principal Investigator:
          • Sang Eok Lee, Dr
    • Gangwon-Do
      • Chuncheon, Gangwon-Do, Korea, Republic of, 200-722
        • Not yet recruiting
        • Kangwon National University Hospital
        • Contact:
        • Principal Investigator:
          • Sung Bae Park, Dr
    • Gyeongbuk
      • Gyeongju, Gyeongbuk, Korea, Republic of, 780-350
        • Not yet recruiting
        • Dongguk University Gyeongju Hospital
        • Contact:
          • Jung Min Bae, Dr
          • Phone Number: +82-54-770-8217
        • Principal Investigator:
          • Jung Min Bae, Dr
    • Gyeonggi-Do
      • Ansan, Gyeonggi-Do, Korea, Republic of, 425-707
        • Not yet recruiting
        • Korea University Ansan Hospital
        • Contact:
        • Principal Investigator:
          • Jong Han Kim, Dr
      • Goyang, Gyeonggi-Do, Korea, Republic of, 410-773
        • Not yet recruiting
        • Dongguk University Medical Center
        • Contact:
        • Principal Investigator:
          • Yong Hae Baik, Dr
      • Suwon, Gyeonggi-Do, Korea, Republic of, 442-723
        • Not yet recruiting
        • The Catholic University Of Korea St. Vincent's Hospital
        • Contact:
      • Suwon, Gyeonggi-Do, Korea, Republic of, 443-380
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:
        • Principal Investigator:
          • Sang-Uk Han, Dr
    • Gyeonggi-do
      • Guri, Gyeonggi-do, Korea, Republic of, 471-701
        • Not yet recruiting
        • Hanyang University Guri Hospital
        • Contact:
          • Min Gyu Kim, Dr
          • Phone Number: +82-31-560-2114
        • Principal Investigator:
          • Min Gyu Kim, Dr
    • Gyeongsangnam-Do
      • Jinjoo, Gyeongsangnam-Do, Korea, Republic of, 660-702
        • Not yet recruiting
        • Gyengsang National University Hospital
        • Contact:
        • Principal Investigator:
          • Young Joon Lee, Dr
        • Sub-Investigator:
          • Sang Ho Jeong, Dr
    • Gyunggi-Do
      • Goyang, Gyunggi-Do, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center
        • Contact:
        • Principal Investigator:
          • Young Woo Kim, Ph.D
        • Sub-Investigator:
          • Keun Won Ryu, Ph.D
        • Sub-Investigator:
          • Hong Man Yoon, M.D.
        • Sub-Investigator:
          • Bang Wool Eom, M.D. M.S.
        • Sub-Investigator:
          • Myeong Chul Kook, Ph.D
        • Sub-Investigator:
          • Soo Jin Kim, Ph.D
        • Sub-Investigator:
          • Byung Ho Nam, Ph.D
    • Jeju Special Self-Governing Province
      • Jeju, Jeju Special Self-Governing Province, Korea, Republic of, 690-767
        • Not yet recruiting
        • Jeju National University Hospital
        • Contact:
        • Principal Investigator:
          • In Ho Jeong, Dr
    • Jellabuk-Do
      • Jeonju, Jellabuk-Do, Korea, Republic of, 561-712
        • Not yet recruiting
        • Chonbuk National University Hospital
        • Contact:
        • Sub-Investigator:
          • Chan Young Kim, Dr
        • Principal Investigator:
          • Doo Hyun Yang, Dr
        • Sub-Investigator:
          • Se-Yul Lee, Dr
    • Jellanam-Do
      • Gwangju, Jellanam-Do, Korea, Republic of, 501-717
        • Not yet recruiting
        • Chosun University Hospital
        • Contact:
          • Young Don Min, Dr
          • Phone Number: +82-62-220-3114
        • Sub-Investigator:
          • Sung Soo Kim, Dr
        • Principal Investigator:
          • Young Don Min, Dr
      • Hwasun-Gun, Jellanam-Do, Korea, Republic of, 519-763
        • Not yet recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
        • Principal Investigator:
          • Young Kyu Park, Dr
        • Sub-Investigator:
          • Sung-Yub Rhu, Dr
        • Sub-Investigator:
          • Mi Ran Jung, Dr
        • Sub-Investigator:
          • Oh Jeong, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: 3 year
3 year disease free survival
3 year
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 year , 5 year
Operating time
Time Frame: op day
Operating time
op day
Early postoperative complications
Time Frame: within 30 days
Early postoperative complications
within 30 days
Long term postoperative complications
Time Frame: after 30 days
Long term postoperative complications
after 30 days
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)
baseline, 1 week, 1month, 6 month, 1 year, 3 year
Overall cost for the treatment
Time Frame: operation day to discharge
Overall cost for the treatment (from operative day to discharge day)
operation day to discharge
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
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Young Woo Kim, PhD, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-13-712

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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