A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)

A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405) - A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000094

Enrollment

Registered

2005-08-30

Start date

2005-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric neoplasm

Interventions

Preoperative chemotherapy with TS-1+CDDP followed by gastrectomy with D3 lymph node dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric carcinoma 2) Macroscopic type 0, 1, 2, 3, 5 3) N3 (paraaortic) or bulky N2 metastases by CT 4) Thoracic/ abdominal/ pelvic enhanced CTrevealed none of the following: i) Mediastinal lymph node metastais ii) Cervical lymph node metastasis iii) Lung metastasis iv) Peritoneal metastasis, liver metastasis v) Pleural effusion, ascites beyond the pelvis vi) Paraaortic #16a1 or #16b2 swelling 1cm or greater vii) Other distant metastasis 5) Esophageal invasion greater than 3cm by endoscopy or X-ray 6) Clinically no sign of distant metastasis 7) No peritoneal metastasis and CY0 by laparoscopy 8) Age between 20 and 75 at registration 9) Performance Status(ECOG) 0 or 1 10) No prior chemotherapy or radiotherapy 11) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic mucosal resection 12) Fair oral intake with or without bypass surgery 13) Blood test i) WBC >= 3,000/mm3 and = 9.0 g/dl iii) Platelet >= 100,000/mm3 iv) GOT = 60ml/min/body ii) Actual Ccr >= 60ml/min/body 15) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Active multiple cancer 2) Probable pregnancy, and the period of lactation 3) Difficulty to join the trial due to psychosis or psychotic symptoms 4) Under treatment with systemic steroid 5) Under treatment with flucytosine, phenytoin, or warfarin 6) Allergy to iodine 7) Serious complications 8) Past history of myocardial infarction withoin 6 months 9) Not fit to the protocol treatment by the physicion's dicision

Design outcomes

Primary

Measure	Time frame
Proportion of curative resection	—

Secondary

Measure	Time frame
3-year survival, proportion of completion of treatment, response rate, toxicities	—

Countries

Japan

Contacts

Public ContactAkira Tsuburaya, MD

JCOG0405 Coordinating Office Gastric Surgery Division, Kanagawa Cancer Center

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026