A randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor (JCOG0705/KGCA01)

Conditions

clinical stage IV gastric cancer

Masanori Terashima, Kazumasa Fujitani, Han‐Kwang Yang, Junki Mizusawa, Toshimasa Tsujinaka et al. (16 authors)

Journal of Clinical Oncology2019-01-29

10.1200/jco.2019.37.4_suppl.109

Role of volume reduction gastrectomy according to tumor location in patients with gastric cancer with a single non-curable factor: Supplementary analysis of REGATTA trial (JCOG0705/KGCA01).

Kazumasa Fujitani, Masanori Terashima, Han‐Kwang Yang, Junki Mizusawa, Toshimasa Tsujinaka et al. (16 authors)

Journal of Clinical Oncology2018-05-20

10.1200/jco.2018.36.15_suppl.e16038

Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial.

Fujitani K, Yang HK, Mizusawa J, Kim YW, Terashima M, Han SU, Iwasaki Y, Hyung WJ, Takagane A, Park DJ, Yoshikawa T, Hahn S, Nakamura K, Park CH, Kurokawa Y, Bang YJ, Park BJ, Sasako M, Tsujinaka T, REGATTA study investigators.

2016-01-26500 citations

10.1016/s1470-2045(15)00553-7

Randomized controlled trial of comparing gastrectomy (Gx) plus chemotherapy (CTX) with CTX alone in advanced gastric cancer (AGC) with a single non-curable factor: JCOG 0705/KGCA01 study (REGATTA).

Han‐Kwang Yang, Toshimasa Tsujinaka, Kenichi Nakamura, Young‐Woo Kim, Masanori Terashima et al. (14 authors)

Journal of Clinical Oncology2015-05-208 citations

10.1200/jco.2015.33.15_suppl.200

Interventions

A: Chemotherapy alone (S-1 80mg/m2 on days 1-21

CDDP 60mg/m2 on day 8, every 5 weeks) B: Gastrectomy with D1 lymphadenectomy followed by chemotherapy (S-1 80mg/m2 on days 1-21

CDDP 60mg/m2 on day 8, every 5 weeks)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven primary gastric adenocarcinoma. 2) Presence of distant metastases confined to either liver (H1), peritoneum (P1), or para-aortic lymphnode (16a1/b2), which is confirmed by both CT scan and laparotomy. 3) Clinical T1-3. 4) No other distant metastasis than H1, P1or M1(LN 16a1/b2). 5) No apparent pleural effusion. 6) Length of esophageal invasion 3cm or less with no need of thoracotomy for resection. 7) Aged 20 to 75 years old. 8) PS of 0 or 1. 9) Sufficient oral intake without active bleeding from the gastric tumor. 10) No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer except EMR. 11) Adequate organ functions defined as indicated below (1)WBC >= 3,000 /mm3 , WBC <= 12,000 /mm3 (2)Hb >= 8.0 g/dL without any transfusion 2 weeks before enrollment (3)Plt >= 100,000 /mm3 (4)AST <= 100 IU/L (5)ALT <= 100 IU/L (6)T.Bil <= 2.0 mg/dL (7)Cr <= 1.2 mg/dL (8)Ccr >= 60 mL/min/body 12) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 2) Women during pregnancy or breast-feeding. 3) Psychosis. 4) Systemic steroids medication. 5) Medication of furucytocin, fenytoin, or warfarin. 6) Active bacterial infection or mycosis, affecting systemic condition. 7) Myocardial infarction or unstable angina, occurred within 6 months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes mellitus or administration of insulin. 10) Pulmonary disease necessitating continuous oxygen supply.

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
progression-free survival, adverse events	—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactKazumasa Fujitani

JCOG0705 Coordinating Office National Hospital Organization Osaka National Hospital, Department of Surgery

JCOG_sir@ml.jcog.jp06-6942-1331

Outcome results

None listed