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

Gastric Adenocarcinoma Clinical Trial

— ADDICT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02144727
• Other study ID #: NCCCTS-13-712
• Status: Recruiting
• Phase: Phase 3
• First received: March 4, 2014
• Last updated: April 18, 2016
• Start date: January 2014
• Est. completion date: December 2021

Study information

• Verified date: April 2016
• Source: National Cancer Center, Korea
• Contact: Young Woo Kim, Ph.D
• Phone: 82-31-920-1635
• Email: gskim[@]ncc.re.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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 ).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1880
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggi-Do
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Dongnam Inst. Of Radiological & Medical Sciences	Busan
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan	Chuncheongnam-Do
Korea, Republic of	Kangwon National University Hospital	Chuncheon	Gangwon-Do
Korea, Republic of	Daegu Catholic Univ. Medical Center	Daegu
Korea, Republic of	Daegu Veterans Hospital	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kungpook National University Hospital	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Dongguk University Medical Center	Goyang	Gyeonggi-Do
Korea, Republic of	National Cancer Center	Goyang	Gyunggi-Do
Korea, Republic of	Hanyang University Guri Hospital	Guri	Gyeonggi-do
Korea, Republic of	Chosun University Hospital	Gwangju	Jellanam-Do
Korea, Republic of	Dongguk University Gyeongju Hospital	Gyeongju	Gyeongbuk
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-Gun	Jellanam-Do
Korea, Republic of	Gachon University Gill Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	The Catholic University of Korea Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju	Jeju Special Self-Governing Province
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jellabuk-Do
Korea, Republic of	Gyengsang National University Hospital	Jinjoo	Gyeongsangnam-Do
Korea, Republic of	Konyang University Hospital	Metropolitan City Daejon	Daejon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Ewha Womans University Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Sacred Heart Hospital	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul Red Cross Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul
Korea, Republic of	The Catholic University of Korea St. Mary's Hospital	Seoul
Korea, Republic of	VHS Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-Do
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Suwon	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	To test non-inferiority of survival of D1+ gastrectomy versus D2 gastrectomy for clinical stage I B & II advanced gastric cancer	5 year	Yes
Secondary	disease free survival	3 year disease free survival	3 year	Yes
Secondary	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	3 year , 5 year	Yes
Secondary	Operating time	Operating time	op day	Yes
Secondary	Early postoperative complications	Early postoperative complications	within 30 days	Yes
Secondary	Long term postoperative complications	Long term postoperative complications	after 30 days	Yes
Secondary	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)	baseline, 1 week, 1month, 6 month, 1 year, 3 year	No
Secondary	Overall cost for the treatment	Overall cost for the treatment (from operative day to discharge day)	operation day to discharge	No
Secondary	Finding biomarkers predicting lymph node metastasis and recurrence	Finding biomarkers predicting lymph node metastasis and recurrence for prediction of lymph node metastasis and recurrence	3 year	No