Phase II study of Ccr-based dose-control of S-1 in the first-line chemotherapy of S-1/oxaliplatin(SOX)+bevacizumab regimen for advanced colorectal cancer

Phase II study of Ccr-based dose-control of S-1 in the first-line chemotherapy of S-1/oxaliplatin(SOX)+bevacizumab regimen for advanced colorectal cancer - B-Tune study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015446

Enrollment

Registered

2014-10-17

Start date

2014-10-20

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

colorectal cancer

Interventions

Ccr-based dose-control of S-1 in the first-line chemotherapy of S-1/oxaliplatin(SOX)+bevacizumab regimen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histopathologically confirmed adenocarcinoma. 2. Patients with unresectable recurrent or advanced colorectal cancer. 3. Patients 20 years or older. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 5. unresectable primary tumor or with one or more unresectable metastatic tumor Measurable or evaluable disease. (RECIST 1.1) 6. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment. 7. Patients with sufficient oral intake. 8. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. i. Leukocyte >=3,000/mm3 Neutrophil >=1,500/mm3 ii. Platelets >=100,000/mm3 iii. Hemoglobin >=9.0g/dl iv. Total bilirubin <= 1.5ml/dl v. AST and ALT <= 100IU/l (150IU/l in case of liver metastasis) vi. Serum creatinine <= 1.3mg/dl vii. INR < 1.5 viii. urinary protein <= 1+ 7. survival more than 3 months. 8. Patients with written informed consent.

Exclusion criteria

Exclusion criteria: 1. With a history of severe drug allergic response 2. Pregnant or lactating women or women of childbearing potential. 3. Uncontrolled infection. 4. With a history of severe systemic diseases. 5. Evidence of cardiovascular abnormalities. 6. Evidence of gastrointestinal bleeding 7. Evidence of sensory disturbance 8. Evidence of severe diarrhea 9. Evidence of ascites or pleural effusion needed to treat. 10. Evidence of gstrointestinal obstraction. 11. Evidence of peritoneal dissemination 12. Evidence of brain metastasis 13. History of hematemesis 14. History of cardiovascular events including unstable angina, cardiac infarction, cerebral infarction and pulmonary embolism 15. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks. 16. Evidence of bleeding diathesis or coagulopathy. 17. Administering antithrombotic drugs 18. blood transfusion within 2 weeks. 19. Multiple primary cancers within 5 years. 20. patients with administration of steroids. 21. Patients who have active hepatitis type B. 22. contraindication of S-1, L-OHP, BV administration 23. Other conditions not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Adverse events	—

Secondary

Measure	Time frame
OS PFS RR TTF RDI R0 resectability ETS	—

Countries

Japan

Contacts

Public ContactDai Manaka

Kyoto-Katsura Hospital Department of Surgery

noriko.fujita@katsura.com075-391-5811

Outcome results

None listed

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