Gastric AdenocarcinomaPhase 3ADDICTNCT02144727
A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
A Phase 3 study testing D2 distal subtotal gastrectomy and D1+ distal subtotal gastrectomy in people with Gastric Adenocarcinoma, run by National Cancer Center, Korea at 50 sites in South Korea.
Trial summary
In oncological aspect, D1+ lymph node dissection would be enough for early stage gastric cancer in advanced gastric cancer (stage IB/IIA/IIB ). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- D2 distal subtotal gastrectomy and D1+ distal subtotal gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,880 participants
- Where
- 50 sitesSouth Korea
- Study dates
- Jan 2014to Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
South Korea50 sites, 50 recruiting
- Not yet recruiting
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 425-707
Jong Han Kim, Dr, +82-31-412-5030, ppongttai@gmail.com
Jong Han Kim, Dr
- Not yet recruiting
Kosin University Gospel Hospital
Busan, Busan, 602-702
Sang Ho Lee, Dr, +82-10-2867-8177, gslsh@kosinmed.or.kr
Kyung Won Seo, Dr
- Not yet recruiting
Pusan National University Hospital
Busan, Busan, 602-739
Dong Heon Kim, Dr, +82-10-4004-1134, kdhun@pusan.ac.kr
Dae Hwan Kim, Dr
- Not yet recruiting
Dong-A University Hospital
Busan, Busan, 602-812
Ki-Han Kim, Dr, +82-51-240-2643
Ki-Han Kim, Dr
- Not yet recruiting
Dongnam Inst. Of Radiological & Medical Sciences
Busan, Busan, 619-953
Jae-Seok Min, Dr, +82-10-9567-9488, mdoogy@hanmail.net
Jae-Seok Min, Dr
- Not yet recruiting
Inje University Haeundae Paik Hospital
Busan, Busan, Busan 612-896
Byoung-Jo Suh, Dr, +82-11-899-7365, oltx62@hotmail.com
Byoung-Jo Suh, Dr
- Not yet recruiting
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chuncheongnam-Do, 330-721
Moon Soo Lee, Dr, +82-41-570-2114
Moon Soo Lee, Dr
- Not yet recruiting
Kangwon National University Hospital
Chuncheon, Gangwon-do, 200-722
Sung Bae Park, Dr, +82-10-2001-8566, bsb1971_kr@kangwon.ac.kr
Sung Bae Park, Dr
- Not yet recruiting
Keimyung University Dongsan Medical Center
Daegu, Daegu, 700-712
Seung Wan Ryu, Dr, +82-11-522-9659, gsman@dsmc.or.kr
Seung Wan Ryu, Dr
- Not yet recruiting
Kyungpook National University Hospital
Daegu, Daegu, 700-721
Ho Young Chung, Dr, +82-53-200-5601
Ho Young Chung, Dr
- Not yet recruiting
Kungpook National University Hospital
Daegu, Daegu, 702-210
Wansik Yu, Dr, +82-10-9069-0365, wyu@knu.ac.kr
O Kyoung Kwon, Dr
- Not yet recruiting
Daegu Veterans Hospital
Daegu, Daegu, 704-802
Taebong Kim, Dr, +82-10-4137-8022, tkimchr@medigate.net
Taebong Kim, Dr
- Not yet recruiting
Yeungnam University Medical Center
Daegu, Daegu, 705-703
Se Won Kim, Dr, kswgs@ynu.ac.kr
Se Won Kim, Dr
- Not yet recruiting
Daegu Catholic Univ. Medical Center
Daegu, Daegu, 705-718
Hyun Dong Chae, Dr, +82-53-650-4065, surgery@cu.ac.kr
Hyun Dong Chae, Dr
- Not yet recruiting
Chungnam National University Hospital
Daejeon, Daejeon, 301-721
Ji Young Sul, Dr, +82-10-5420-8369, jsul@cnu.ac.kr
Ji Young Sul, Dr
- Recruiting
National Cancer Center
Goyang, Gyunggi-Do, 410-769
Young Woo Kim, PhD., +82-31-920-1635, gskim@ncc.re.kr
Young Woo Kim, Ph.D
- Not yet recruiting
Dongguk University Medical Center
Goyang-si, Gyeonggi-do, 410-773
Yong Hae Baik, Dr, +82-10-6320-9229, Whitedrag@naver.com
Yong Hae Baik, Dr
- Not yet recruiting
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701
Min Gyu Kim, Dr, +82-31-560-2114
Min Gyu Kim, Dr
- Not yet recruiting
Chosun University Hospital
Gwangju, Jellanam-Do, 501-717
Young Don Min, Dr, +82-62-220-3114
Sung Soo Kim, Dr
- Not yet recruiting
Dongguk University Gyeongju Hospital
Gyeongju, Gyeongsangbuk-do, 780-350
Jung Min Bae, Dr, +82-54-770-8217
Jung Min Bae, Dr
- Not yet recruiting
Chonnam National University Hwasun Hospital
Hwasun-Gun, Jellanam-Do, 519-763
Young Kyu Park, Dr, +82-10-7173-1196, parkyk@jnu.ac.kr
Young Kyu Park, Dr
- Not yet recruiting
Inha University Hospital
Incheon, Incheon, 400-711
Yoon Seok Heo, Dr, +82-32-890-3431, gshur@inha.ac.kr
Yoon Seok Heo, Dr
- Not yet recruiting
The Catholic University of Korea Incheon St. Mary's Hospital
Incheon, Incheon, 403-720
Jinjo Kim, Dr, +82-2-1544-9004, kjj@catholic.ac.kr
Jin-Jo Kim, Dr
- Not yet recruiting
Gachon University Gill Medical Center
Incheon, Incheon, 405-760
Woon Ki Lee, Dr, +82-10-8945-6007, lwk@gilhospital.com
Woon Ki Lee, Dr
- Not yet recruiting
Jeju National University Hospital
Jeju City, Jeju Special Self-Governing Province, 690-767
In Ho Jeong, Dr, +82-10-3644-2240, 41056@naver.com
In Ho Jeong, Dr
- Not yet recruiting
Chonbuk National University Hospital
Jeonju, Jellabuk-Do, 561-712
Doo Hyun Yang, Dr, +82-10-4905-6291, ydh@chonbuk.ac.kr
Chan Young Kim, Dr
- Not yet recruiting
Gyengsang National University Hospital
Jinjoo, Gyeongsangnam-do, 660-702
Young Joon Lee, Dr, +82-10-5060-3214, orangejulia@naver.com
Young Joon Lee, Dr
- Not yet recruiting
Konyang University Hospital
Metropolitan City Daejon, Daejon, 302-718
Sang Eok Lee, Dr, +82-10-6432-6399, srglee@hanmail.net
Sang Eok Lee, Dr
- Not yet recruiting
Seoul National University Hospital
Seoul, Seoul, 110-744
Han-Kwang Yang, Dr, +82-10-5216-0032, hkyang@snu.ac.kr
Seong-Ho Kong, Dr
- Not yet recruiting
Seoul Red Cross Hospital
Seoul, Seoul, 110-747
Dong Gue Shin, Dr, +82-2-2002-8380, shinedk@seoulmc.or.kr
Dong Gue Shin, Dr
- Not yet recruiting
Severance Hospital
Seoul, Seoul, 120-752
Woo-Jin Hyung, Dr, +82-2-2228-5170
In Kyu Kwon, Dr
- Not yet recruiting
KyungHee University Medical Center
Seoul, Seoul, 130-872
Yong Ho Kim, Dr, +82-10-6540-8262, kyjho@khmc.or.kr
Yong Ho Kim, Dr
- Not yet recruiting
Hanyang University Medical Center
Seoul, Seoul, 133-792
Sung Joon Kwon, Dr, +82-10-2014-4398, sjkwon@hanyang.ac.kr
Sung Joon Kwon, Dr
- Not yet recruiting
Kyung Hee University Hospital at Gangdong
Seoul, Seoul, 134-727
Sung Il Choi, Dr, +82-10-3974-1654, drchoi@khu.ac.kr
Sung Il Choi, Dr
- Not yet recruiting
VHS Medical Center
Seoul, Seoul, 134-791
Ho-Geun Yoon, Dr, +82-2-2225-1234
Ho-Geun Yoon, Dr
- Not yet recruiting
Samsung Medical Center
Seoul, Seoul, 135-710
Jae-Moon Bae, Ph.D, +82-10-8843-1625, jmoonbae60@yahoo.co.kr
Jae-Moon Bae, Ph.D
- Not yet recruiting
Gangnam Severance Hospital
Seoul, Seoul, 135-720
Seung-Ho Choi, Dr, +82-10-3276-1466, choish@yumc.yonsei.ac.kr
Seung-Ho Choi, Dr
- Not yet recruiting
Korea University Anam Hospital
Seoul, Seoul, 136-705
Seong Heum Park, Dr, +82-10-8992-3973, pshchw@korea.ac.kr
Sung Heum Park, Dr
- Not yet recruiting
The Catholic University of Korea St. Mary's Hospital
Seoul, Seoul, 137-701
Hae-Myung Jeon, Dr, +82-10-9066-5231, hmjeon@catholic.ac.kr
Kyo-Young Song, Dr
- Not yet recruiting
Asan Medical Center
Seoul, Seoul, 138-736
Jeong Hwan Yook, Dr, +82-10-2258-8826, jhyook@amc.seoul.kr
Byung-Sik Kim, Dr
- Not yet recruiting
Korea Cancer Center Hospital
Seoul, Seoul, 139-709
Hang Jong Yu, Dr, +82-10-9253-5463, imyst@hanafos.com
Hang Jong Yu, Dr
- Not yet recruiting
Soon Chun Hyang University Hospital Seoul
Seoul, Seoul, 140-887
Yong Jin Kim, Dr, +82-10-5382-6758, yjkim@hosp.sch.ac.kr
Yong Jin Kim, Dr
- Not yet recruiting
Konkuk University Medical Center
Seoul, Seoul, 143-729
Ho-Yoon Bang, Dr, +82-10-6297-0629, bangstca@kcch.re.kr
Ho-Yoon Bang, Dr
- Not yet recruiting
Hallym University Sacred Heart Hospital
Seoul, Seoul, 150-037
Man Sup Lim, Dr, +82-10-3270-2988, ellemes@hanmail.net
Dae Hyun Yang, Dr
- Not yet recruiting
Korea University Guro Hospital
Seoul, Seoul, 152-703
Young Jae Mok, Dr, +82-10-2686-6587, yjmok@kumc.ac.kr
Young Jae Mok, Dr
- Not yet recruiting
SMG-SNU Boramae Medical Center
Seoul, Seoul, 156-707
Hye Sung Ahn, Dr, +82-2-2072-3797
Hye Sung Ahn, Dr
- Not yet recruiting
Chung-Ang University Hospital
Seoul, Seoul, 156-755
Kyeung Chun Chi, Dr, +82-16-649-9874, kcchi@cau.ac.kr
Joong-Min Park, Dr
- Not yet recruiting
Ewha Womans University Medical Center
Seoul, Seoul, 158-710
Joo Ho Lee, Dr, gsljh@ewha.ac.kr
Yong Il Kim, Dr
- Not yet recruiting
The Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723
Hyung Min Chin, Dr, +82-31-249-7170, hchin@catholic.ac.kr
- Not yet recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 443-380
Sang-Uk Han, Dr, +82-10-2911-9336, hansu@ajou.ac.kr
Sang-Uk Han, Dr
About this study
Official title: 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 ).
Read the 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.
- 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.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- D2 distal subtotal gastrectomy, D1+ distal subtotal gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D2 distal subtotal gastrectomyProcedure or surgery
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.
D1+ distal subtotal gastrectomyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| D2 distal subtotal gastrectomy | Active comparator | 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 Receives: Procedure: D2 distal subtotal gastrectomy |
| D1+ distal subtotal gastrectomy | Experimental | 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 Receives: Procedure: D1+ distal subtotal gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B \& II advanced gastric cancer
Measured: 5 year
Secondary outcomes (8)
disease free survival
3 year disease free survival
Measured: 3 year
Subgroup analysis of Laparoscopic surgery versus open surgery
Subgroup analysis of Laparoscopic surgery versus open surgery in terms of 3 year relapse free survival and 5 year overall survival
Measured: 3 year , 5 year
Operating time
Operating time
Measured: op day
Early postoperative complications
Early postoperative complications
Measured: within 30 days
Long term postoperative complications
Long term postoperative complications
Measured: after 30 days
Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Measured: baseline, 1 week, 1month, 6 month, 1 year, 3 year
Overall cost for the treatment
Overall cost for the treatment (from operative day to discharge day)
Measured: operation day to discharge
Finding biomarkers predicting lymph node metastasis and recurrence
Finding biomarkers predicting lymph node metastasis and recurrence for prediction of lymph node metastasis and recurrence
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Young-Woo Kim, National Cancer Center, Korea
- Investigators
- Young Woo Kim, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144727
- Sponsor's protocol ID
- NCCCTS-13-712
- Acronym
- ADDICT
- Status last verified
- Apr 2016
- First submitted
- 4 Mar 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT02144727
- Acronym / sponsor ID
- ADDICT / NCCCTS-13-712
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,880 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jan 2014
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 distal subtotal gastrectomy | Active comparator | Procedure: D2 distal subtotal gastrectomyD2 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 |
| D1+ distal subtotal gastrectomy | Experimental | Procedure: D1+ distal subtotal gastrectomyD1+ 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D2 distal subtotal gastrectomyD2 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 or surgery | D2 distal subtotal gastrectomy |
| D1+ distal subtotal gastrectomyD1+ 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 or surgery | D1+ distal subtotal gastrectomy |
Primary outcome
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
8 secondary outcomes
disease free survival
Time frame: 3 year
Subgroup analysis of Laparoscopic surgery versus open surgery
Time frame: 3 year , 5 year
Operating time
Time frame: op day
Early postoperative complications
Time frame: within 30 days
Long term postoperative complications
Time frame: 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
Overall cost for the treatment
Time frame: operation day to discharge
Finding biomarkers predicting lymph node metastasis and recurrence
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
Related trials for Gastric Adenocarcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Woo Kim, PhD principal investigator
National Cancer Center, Korea
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D2 distal subtotal gastrectomy and D1+ distal subtotal gastrectomy in people with Gastric Adenocarcinoma, run by National Cancer Center, Korea at 50 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Woo Kim, Ph.D (82-31-920-1635, gskim@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.