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Prospective Cohort Study Evaluating the Prognosis of Patients with Resectable Large 3 and 4 Type Gastric Cancer and Clinical Phase II trial Evaluating the Safety and Benefit of Perioperative Chemotherapy for Resectable Large 3 and 4 Type Gastric Cancer

Prospective Cohort Study Evaluating the Prognosis of Patients with Resectable Large 3 and 4 Type Gastric Cancer and Clinical Phase II trial Evaluating the Safety and Benefit of Perioperative Chemotherapy for Resectable Large 3 and 4 Type Gastric Cancer - CoBLa trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013491
Enrollment
40
Registered
2014-03-24
Start date
2014-01-01
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 cancer

Interventions

Sponsors

Department of Surgical Oncology, Kanazawa Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Cohort study 1. pathologically confirmed gastric cancer in biopsy specimens. 2. macrosopic type 3 or 4 3. 8cm and more in case of macrosopic type 3 4. clinical M0, P0, H0, N0-2 5. without any prior therapy 2) Phase II trial Enrolled in cohort study and satisfy the following conditions. 1. esophageal invasion length is 3cm or less 2. diagnostic laparoscopy(option) shows POCY0 or POCY1. 3. age: 20 and more 4. PS(ECOG): 0-2 5. patients who can take medicine orally 6. with adequate major organ functions within 14 days before trial entry. 7. written informed consents

Exclusion criteria

Exclusion criteria: 1. administration contraindication of TS-1, CDDP, DOC, PAC 2. severe complications such as paralytic ileus, bowel obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure etc. 3. massive ascites or pleural effusion 4. severe watery diarrhea 5. schronous double cancer 6. pregnancy or lactation 7. physician concludes that the patient's participation in this trial is inappropriate

Design outcomes

Primary

MeasureTime frame
The proportion of the patients who completed the treatment

Secondary

MeasureTime frame
The proportion of adverse events, DFS, and OS.

Countries

Japan

Contacts

Public ContactHiroshi Funaki

Kanazawa Medical University Department of Surgical Oncology

hfunaki@kanazawa-med.ac.jp076-286-2211

Outcome results

None listed

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