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

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT02144727

Collaborator

(none)

1,880

Enrollment

Locations

Arms

Duration (Months)

37.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Type:

Interventional

Anticipated 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 :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

overall survival [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

disease free survival [3 year]
3 year disease free survival
Subgroup analysis of Laparoscopic surgery versus open surgery [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 [op day]
Operating time
Early postoperative complications [within 30 days]
Early postoperative complications
Long term postoperative complications [after 30 days]
Long term postoperative complications
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]
Quality of life of the patients in terms of European quality of life questionnaire (EQ-5D)
Overall cost for the treatment [operation day to discharge]
Overall cost for the treatment (from operative day to discharge day)
Finding biomarkers predicting lymph node metastasis and recurrence [3 year]
Finding biomarkers predicting lymph node metastasis and recurrence for prediction of lymph node metastasis and recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soon Chun Hyang University Hospital Cheonan	Cheonan	Chuncheongnam-Do	Korea, Republic of	330-721
2	Konyang University Hospital	Metropolitan City Daejon	Daejon	Korea, Republic of	302-718
3	Kangwon National University Hospital	Chuncheon	Gangwon-Do	Korea, Republic of	200-722
4	Dongguk University Gyeongju Hospital	Gyeongju	Gyeongbuk	Korea, Republic of	780-350
5	Korea University Ansan Hospital	Ansan	Gyeonggi-Do	Korea, Republic of	425-707
6	Dongguk University Medical Center	Goyang	Gyeonggi-Do	Korea, Republic of	410-773
7	Hanyang University Guri Hospital	Guri	Gyeonggi-do	Korea, Republic of	471-701
8	The Catholic University of Korea St. Vincent's Hospital	Suwon	Gyeonggi-Do	Korea, Republic of	442-723
9	Ajou University Hospital	Suwon	Gyeonggi-Do	Korea, Republic of	443-380
10	Gyengsang National University Hospital	Jinjoo	Gyeongsangnam-Do	Korea, Republic of	660-702
11	National Cancer Center	Goyang	Gyunggi-Do	Korea, Republic of	410-769
12	Jeju National University Hospital	Jeju	Jeju Special Self-Governing Province	Korea, Republic of	690-767
13	Chonbuk National University Hospital	Jeonju	Jellabuk-Do	Korea, Republic of	561-712
14	Chosun University Hospital	Gwangju	Jellanam-Do	Korea, Republic of	501-717
15	Chonnam National University Hwasun Hospital	Hwasun-Gun	Jellanam-Do	Korea, Republic of	519-763
16	Kosin University Gospel Hospital	Busan		Korea, Republic of	602-702
17	Pusan National University Hospital	Busan		Korea, Republic of	602-739
18	Dong-A University Hospital	Busan		Korea, Republic of	602-812
19	Dongnam Inst. Of Radiological & Medical Sciences	Busan		Korea, Republic of	619-953
20	Inje University Haeundae Paik Hospital	Busan		Korea, Republic of	Busan 612-896
21	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of	700-712
22	Kyungpook National University Hospital	Daegu		Korea, Republic of	700-721
23	Kungpook National University Hospital	Daegu		Korea, Republic of	702-210
24	Daegu Veterans Hospital	Daegu		Korea, Republic of	704-802
25	Yeungnam University Medical Center	Daegu		Korea, Republic of	705-703
26	Daegu Catholic Univ. Medical Center	Daegu		Korea, Republic of	705-718
27	Chungnam National University Hospital	Daejeon		Korea, Republic of	301-721
28	Inha University Hospital	Incheon		Korea, Republic of	400-711
29	The Catholic University of Korea Incheon St. Mary's Hospital	Incheon		Korea, Republic of	403-720
30	Gachon University Gill Medical Center	Incheon		Korea, Republic of	405-760
31	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
32	Seoul Red Cross Hospital	Seoul		Korea, Republic of	110-747
33	Severance Hospital	Seoul		Korea, Republic of	120-752
34	KyungHee University Medical Center	Seoul		Korea, Republic of	130-872
35	Hanyang University Medical Center	Seoul		Korea, Republic of	133-792
36	Kyung Hee University Hospital at Gangdong	Seoul		Korea, Republic of	134-727
37	VHS Medical Center	Seoul		Korea, Republic of	134-791
38	Samsung Medical Center	Seoul		Korea, Republic of	135-710
39	Gangnam Severance Hospital	Seoul		Korea, Republic of	135-720
40	Korea University Anam Hospital	Seoul		Korea, Republic of	136-705
41	The Catholic University of Korea St. Mary's Hospital	Seoul		Korea, Republic of	137-701
42	Asan Medical Center	Seoul		Korea, Republic of	138-736
43	Korea Cancer Center Hospital	Seoul		Korea, Republic of	139-709
44	Soon Chun Hyang University Hospital Seoul	Seoul		Korea, Republic of	140-887
45	Konkuk University Medical Center	Seoul		Korea, Republic of	143-729
46	Hallym University Sacred Heart Hospital	Seoul		Korea, Republic of	150-037
47	Korea University Guro Hospital	Seoul		Korea, Republic of	152-703
48	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of	156-707
49	Chung-Ang University Hospital	Seoul		Korea, Republic of	156-755
50	Ewha Womans University Medical Center	Seoul		Korea, Republic of	158-710

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

Apr 20, 2016

Last Verified:

Apr 1, 2016

Additional relevant MeSH terms:

Adenocarcinoma

Stomach Neoplasms

Study Results

No Results Posted as of Apr 20, 2016