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

NCT02144727 | Unknown Phase 3 DMC

• 1 other identifier: NCCCTS-13-712
• Study Type: interventional
• Target: 1,880
• Locations: 1 country
• Sites: 50

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 ).

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• disease free survival

  3 year

• Subgroup analysis of Laparoscopic surgery versus open surgery

  3 year , 5 year

• Operating time

  op day

• Early postoperative complications

  within 30 days

• Long term postoperative complications

  after 30 days

Study Arms (2)

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

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

Procedure: D1+ distal subtotal gastrectomy

Interventions

D2 distal subtotal gastrectomy PROCEDURE

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.

D2 distal subtotal gastrectomy

D1+ distal subtotal gastrectomy PROCEDURE

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

D1+ distal subtotal gastrectomy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (50)

Kosin University Gospel Hospital

Busan, Busan, 602-702, South Korea

NOT YET RECRUITING

Pusan National University Hospital

Busan, Busan, 602-739, South Korea

NOT YET RECRUITING

Dong-A University Hospital

Busan, Busan, 602-812, South Korea

NOT YET RECRUITING

Dongnam Inst. Of Radiological & Medical Sciences

Busan, Busan, 619-953, South Korea

NOT YET RECRUITING

Inje University Haeundae Paik Hospital

Busan, Busan, Busan 612-896, South Korea

NOT YET RECRUITING

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chuncheongnam-Do, 330-721, South Korea

NOT YET RECRUITING

Keimyung University Dongsan Medical Center

Daegu, Daegu, 700-712, South Korea

NOT YET RECRUITING

Kyungpook National University Hospital

Daegu, Daegu, 700-721, South Korea

NOT YET RECRUITING

Kungpook National University Hospital

Daegu, Daegu, 702-210, South Korea

NOT YET RECRUITING

Daegu Veterans Hospital

Daegu, Daegu, 704-802, South Korea

NOT YET RECRUITING

Yeungnam University Medical Center

Daegu, Daegu, 705-703, South Korea

NOT YET RECRUITING

Daegu Catholic Univ. Medical Center

Daegu, Daegu, 705-718, South Korea

NOT YET RECRUITING

Chungnam National University Hospital

Daejeon, Daejeon, 301-721, South Korea

NOT YET RECRUITING

Konyang University Hospital

Metropolitan City Daejon, Daejon, 302-718, South Korea

NOT YET RECRUITING

Kangwon National University Hospital

Chuncheon, Gangwon-do, 200-722, South Korea

NOT YET RECRUITING

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 425-707, South Korea

NOT YET RECRUITING

Dongguk University Medical Center

Goyang-si, Gyeonggi-do, 410-773, South Korea

NOT YET RECRUITING

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 471-701, South Korea

NOT YET RECRUITING

The Catholic University of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do, 442-723, South Korea

NOT YET RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, 443-380, South Korea

NOT YET RECRUITING

Dongguk University Gyeongju Hospital

Gyeongju, Gyeongsangbuk-do, 780-350, South Korea

NOT YET RECRUITING

Gyengsang National University Hospital

Jinjoo, Gyeongsangnam-do, 660-702, South Korea

NOT YET RECRUITING

National Cancer Center

Goyang, Gyunggi-Do, 410-769, South Korea

RECRUITING

Inha University Hospital

Incheon, Incheon, 400-711, South Korea

NOT YET RECRUITING

The Catholic University of Korea Incheon St. Mary's Hospital

Incheon, Incheon, 403-720, South Korea

NOT YET RECRUITING

Gachon University Gill Medical Center

Incheon, Incheon, 405-760, South Korea

NOT YET RECRUITING

Jeju National University Hospital

Jeju City, Jeju Special Self-Governing Province, 690-767, South Korea

NOT YET RECRUITING

Chonbuk National University Hospital

Jeonju, Jellabuk-Do, 561-712, South Korea

NOT YET RECRUITING

Chosun University Hospital

Gwangju, Jellanam-Do, 501-717, South Korea

NOT YET RECRUITING

Chonnam National University Hwasun Hospital

Hwasun-Gun, Jellanam-Do, 519-763, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

NOT YET RECRUITING

Seoul Red Cross Hospital

Seoul, Seoul, 110-747, South Korea

NOT YET RECRUITING

Severance Hospital

Seoul, Seoul, 120-752, South Korea

NOT YET RECRUITING

KyungHee University Medical Center

Seoul, Seoul, 130-872, South Korea

NOT YET RECRUITING

Hanyang University Medical Center

Seoul, Seoul, 133-792, South Korea

NOT YET RECRUITING

Kyung Hee University Hospital at Gangdong

Seoul, Seoul, 134-727, South Korea

NOT YET RECRUITING

VHS Medical Center

Seoul, Seoul, 134-791, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

NOT YET RECRUITING

Gangnam Severance Hospital

Seoul, Seoul, 135-720, South Korea

NOT YET RECRUITING

Korea University Anam Hospital

Seoul, Seoul, 136-705, South Korea

NOT YET RECRUITING

The Catholic University of Korea St. Mary's Hospital

Seoul, Seoul, 137-701, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

NOT YET RECRUITING

Korea Cancer Center Hospital

Seoul, Seoul, 139-709, South Korea

NOT YET RECRUITING

Soon Chun Hyang University Hospital Seoul

Seoul, Seoul, 140-887, South Korea

NOT YET RECRUITING

Konkuk University Medical Center

Seoul, Seoul, 143-729, South Korea

NOT YET RECRUITING

Hallym University Sacred Heart Hospital

Seoul, Seoul, 150-037, South Korea

NOT YET RECRUITING

Korea University Guro Hospital

Seoul, Seoul, 152-703, South Korea

NOT YET RECRUITING

SMG-SNU Boramae Medical Center

Seoul, Seoul, 156-707, South Korea

NOT YET RECRUITING

Chung-Ang University Hospital

Seoul, Seoul, 156-755, South Korea

NOT YET RECRUITING

Ewha Womans University Medical Center

Seoul, Seoul, 158-710, South Korea

NOT YET RECRUITING

Study Officials

• Young Woo Kim, PhD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Woo Kim, Ph.D

CONTACT

82-31-920-1635; gskim@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastric Cancer Branch

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: May 22, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

KR (50)