A Clinical Trial of D1+ Versus D2 Distal Gastrectomy for Stage IB & II Advanced Gastric Cancer (ADDICT)
Gastric Adenocarcinoma
About this trial
This is an interventional treatment trial for Gastric Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Soon Chun Hyang University Hospital Cheonan
- Konyang University Hospital
- Kangwon National University Hospital
- Dongguk University Gyeongju Hospital
- Korea University Ansan Hospital
- Dongguk University Medical Center
- Hanyang University Guri Hospital
- The Catholic University of Korea St. Vincent's Hospital
- Ajou University Hospital
- Gyengsang National University Hospital
- National Cancer CenterRecruiting
- Jeju National University Hospital
- Chonbuk National University Hospital
- Chosun University Hospital
- Chonnam National University Hwasun Hospital
- Kosin University Gospel Hospital
- Pusan National University Hospital
- Dong-A University Hospital
- Dongnam Inst. Of Radiological & Medical Sciences
- Inje University Haeundae Paik Hospital
- Keimyung University Dongsan Medical Center
- Kyungpook National University Hospital
- Kungpook National University Hospital
- Daegu Veterans Hospital
- Yeungnam University Medical Center
- Daegu Catholic Univ. Medical Center
- Chungnam National University Hospital
- Inha University Hospital
- The Catholic University of Korea Incheon St. Mary's Hospital
- Gachon University Gill Medical Center
- Seoul National University Hospital
- Seoul Red Cross Hospital
- Severance Hospital
- KyungHee University Medical Center
- Hanyang University Medical Center
- Kyung Hee University Hospital at Gangdong
- VHS Medical Center
- Samsung Medical Center
- Gangnam Severance Hospital
- Korea University Anam Hospital
- The Catholic University of Korea St. Mary's Hospital
- Asan Medical Center
- Korea Cancer Center Hospital
- Soon Chun Hyang University Hospital Seoul
- Konkuk University Medical Center
- Hallym University Sacred Heart Hospital
- Korea University Guro Hospital
- SMG-SNU Boramae Medical Center
- Chung-Ang University Hospital
- Ewha Womans University Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
D2 distal subtotal gastrectomy
D1+ 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
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