A phase III study of laparoscopy assisted versus open distal gastrectomy with nodal dissection for clinical stage I gastric cancer (JCOG0912, cSt-I GC LADG P3)

Conditions

gastric cancer

Takaki Yoshikawa, Masahiko Ando, Junki Mizusawa, Hitoshi Katai, Takanobu Yamada et al. (13 authors)

Journal of Clinical Oncology2020-02-011 citations

10.1200/jco.2020.38.4_suppl.293

Survival outcomes after laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection for clinical stage IA or IB gastric cancer (JCOG0912): a multicentre, non-inferiority, phase 3 randomised controlled trial.

Katai H, Mizusawa J, Katayama H, Morita S, Yamada T, Bando E, Ito S, Takagi M, Takagane A, Teshima S, Koeda K, Nunobe S, Yoshikawa T, Terashima M, Sasako M.

2019-11-19233 citations

10.1016/s2468-1253(19)30332-2

Randomized phase III trial of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer (JCOG0912).

Hitoshi Katai, Junki Mizusawa, Hiroshi Katayama, Shinji Morita, Takanobu Yamada et al. (15 authors)

Journal of Clinical Oncology2019-05-2011 citations

10.1200/jco.2019.37.15_suppl.4020

Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912.

Katai H, Mizusawa J, Katayama H, Takagi M, Yoshikawa T, Fukagawa T, Terashima M, Misawa K, Teshima S, Koeda K, Nunobe S, Fukushima N, Yasuda T, Asao Y, Fujiwara Y, Sasako M.

2016-10-07258 citations

10.1007/s10120-016-0646-9

A phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer (JCOG0912): Analysis of the safety and short-term clinical outcomes.

Masakazu Takagi, Hitoshi Katai, Junki Mizusawa, Kenichi Nakamura, Takaki Yoshikawa et al. (15 authors)

Journal of Clinical Oncology2015-05-206 citations

10.1200/jco.2015.33.15_suppl.4017

Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial.

Hur H, Lee HY, Lee HJ, Kim MC, Hyung WJ, Park YK, Kim W, Han SU.

2015-05-0574 citations

10.1186/s12885-015-1365-z

Interventions

A: Open distal gastrectomy with nodal dissection B: Laparoscopy assisted distal gastrectomy (LADG) with nodal dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric adenocarcinoma. 2) cStage IA(T1N0) or IB(T1N1, T2[MP]N0). 3) In case without preceding endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), either 'cN1' or 'cN0 and no indication of EMR' is eligible. 4) In case with preceding EMR or ESD, the following conditions are fulfilled: i) pathological findings require additional gastrectomy, ii) within 56 days from EMR, iii) no perforation by EMR, iv) resection margin of EMR did not reach to the upper third of the stomach. 5) Tumor located in the middle or lower third of the stomach, and curative resection is expected to be achivable by distal gastrectomy. 6) No invasion to duodenum. 7) Aged 20 to 80 years. 8) PS (ECOG) of 0 or 1. 9) Body mass index less than 30. 10) No history of upper abdominal surgery and no history of intestinal resection. 11) No prior treatment of chemotherapy or radiation therapy against any other malignancies. 12) Sufficient organ functions. 13) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Women during pregnancy or breast-feeding. 5) Severe mental disease. 6) Continuous systemic steroid therapy. 7) Unstable angina pectoris, or history of myocardial infarction within six months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes millutus or administration of insulin. 10) Severe respiratory disease requiring continuous oxygen therapy.

Design outcomes

Primary

Measure	Time frame
Relapse-free survival	—

Secondary

Measure	Time frame
Overall survival , proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes, postoperative QOL	—

Countries

Japan

Contacts

Public ContactHitoshi KATAI

JCOG0912 Coordinating Office Gastric Surgery Division, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp03-3542-2511

Outcome results

None listed