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Phase II study of S-1 and CDDP as neoadjuvant chemotherapy for patients with lymph node metastasis from resectable gastric cancer

Phase II study of S-1 and CDDP as neoadjuvant chemotherapy for patients with lymph node metastasis from resectable gastric cancer - CDDP+S-1 as neoadjuvant chemotherapy for resecatbele lymph node metastatic gastric cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001401
Enrollment
50
Registered
2012-10-01
Start date
2002-04-01
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

Resecatbele lymph node metastatic gastric cancer

Interventions

CDDP 60 mg/m2 one-hour days 8, S-1 80 mg/m2 PO days 1-21, every 35 days for 2 cycles followed by gastrectomy with D2 lymph node dissection

Sponsors

Nihon University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed adenocarcinoma of the stomach, curative resection possible by total body computed tomography (CT) scan. Age 20-80 years old, No prior therapy including surgery, radiotherapy or chemotherapy for current disease, patients who can take medication orally, ECOG performance status 0-1, Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions, Written informed consent.

Exclusion criteria

Exclusion criteria: A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix, patients contraindicated to S-1, A history of severe drug hypersensitivity, Uncontrolled medical conditions , Documented or suspected infection, Patients requiring treatment with corticosteroids except for pre-medication, Hepatitis B or C, patients with diarrhea, Pregnant or lactating women and women of child bearing potential not using contraception, Severe psychiatric disorders, Severe edema, Grade 2 or grater peripheral neuropathy, HIV positive, patients judged by the investigator as unfit to be enrolled in the study.

Design outcomes

Primary

MeasureTime frame
Complete resection rate

Secondary

MeasureTime frame
Compliance of treatment tolerance Response rate Relapse Free Survival (3years)

Countries

Japan

Contacts

Public ContactMitsugu Kochi

Nihon University School of Medicine Department of Digestive Surgery

kochi.mitsugu@nihon-u.ac.jp03-3972-8111

Outcome results

None listed

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