Exploratory Research on Prognosis Factors and Risk-factors of Adverse Drug Reactions in the Adjuvant Chemotherapy with S-1 for Patients with Curatively Resected Gastric Cancer

Exploratory Research on Prognosis Factors and Risk-factors of Adverse Drug Reactions in the Adjuvant Chemotherapy with S-1 for Patients with Curatively Resected Gastric Cancer - JACCRO GC-07 AR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011438

Enrollment

880

Registered

2013-08-12

Start date

2013-07-17

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 Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Among the patients who were registered in JACCRO GC-07 (UMIN000010337), those who meet the following criteria. 1. following items within 14 days before surgery were obtained 1) WBC, ANC, Lymphocyte, ALP, Albumin, CRP 2) Weight 2. CEA and CA19-9 within 28 days before surgery were obtained 3. Written informed Consent

Exclusion criteria

Exclusion criteria: 1. Patients who are judged as inadequate for study enrollment by investigators

Design outcomes

Primary

Measure	Time frame
Correlations between the following items A and B A: 1. 3-year and 5-year relapse-free survival 2. 3-year and 5-year overall survival 3. time to treatment failure 4. side-effects 5. continuity of S-1 administration B: 1. 1) clinical examination: WBC, ANC, Lymphocite, PLF, Hb, bilirubin, AST, ALT, ALP, albumin, CRP, eGFR, creatinine, CCR, 2) Age,3) Sex, 4) Height, 5) Weight, 6) Surgical method, type of surgery, type of re-constraction, 7) number of resected lymphnodes, number of metastatic lymphnodes,8) Stage, 9) Histological classification, 10) lymphatic invasion, vein invasion, 11) tumor markers, 12) PS, 13) medication status and dosage of S-1, 14) medication status of docetaxel. 2. Prognostic nutritional index 3. Glasgow prognostic score 4. Neutrophili/lymphocite ratio 5. body weight loss 6. body mass index	—

Measure

Time frame

Correlations between the following items A and B A: 1. 3-year and 5-year relapse-free survival 2. 3-year and 5-year overall survival 3. time to treatment failure 4. side-effects 5. continuity of S-1 administration B: 1. 1) clinical examination: WBC, ANC, Lymphocite, PLF, Hb, bilirubin, AST, ALT, ALP, albumin, CRP, eGFR, creatinine, CCR, 2) Age,3) Sex, 4) Height, 5) Weight, 6) Surgical method, type of surgery, type of re-constraction, 7) number of resected lymphnodes, number of metastatic lymphnodes,8) Stage, 9) Histological classification, 10) lymphatic invasion, vein invasion, 11) tumor markers, 12) PS, 13) medication status and dosage of S-1, 14) medication status of docetaxel. 2. Prognostic nutritional index 3. Glasgow prognostic score 4. Neutrophili/lymphocite ratio 5. body weight loss 6. body mass index

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Countries

Japan

Contacts

Public ContactMasashi Fujii

Nonprofit Organization Japan Clinical Cancer Research Organization Office

gc07.dc@jaccro.or.jp03-5579-9882

Outcome results