A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial)

A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial) - A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013783

Enrollment

Registered

2014-04-23

Start date

2013-02-01

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

colorectal cancer

Interventions

dose-adjusting Capecitabine + Oxaliplatin + Bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. Age :<=20 years 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 4. Histological confirmation of colorectal cancer. 5. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment. 6. unresectable primary tumor or with one or more unresectable metastatic tumor Measurable or evaluable disease. (RECIST 1.1) 7. survival more than 3 months. 8. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. i. Leukocyte <=12,000/mm&#179;,>=3,000/mm3 ii. Platelets >=100,000/mm3 iii. Hemoglobin >=9.0g/dl iv. Total bilirubin <= 2.0ml/dl v. AST and ALT <= 100IU/l (200IU/l in case of liver metastasis) vi. Serum creatinine male <= 1.8mg/dl female <= 1.35mg/dl vii. INR < 1.5 viii. urinary protein <= 2+

Exclusion criteria

Exclusion criteria: 1. Need to drain malignant celomic fluid. 2. Multiple primary cancers within 5 years. 3. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium. 4. With a history of adverse events related to DPD loss. 5. Evidence of interstinal lung disease, or pulmonary fibrosis. 6. Uncontrolled infection. 7. Difficult for oral intake. 8. Radiological evidence of CNS metastases or brain cancer. 9. Complication of cerebrovascular disease or symptoms within 1 year. 10. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. 11. The patient who is planning the surgical treatment during trial. 12. Administering antithrombotic drug within 10 days. 13. Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS). 14. Evidence of bleeding diathesis or coagulopathy. 15. Uncontrollable ulcer indigestive tract. 16. Renal failure to be treated, 3+ or higher proteinuria within 2 weeks prior to entry. 17. Uncontrolled Hypertension. 18. Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction. 19. Pregnant or lactating women or women of childbearing potential. 20. Other conditions not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Overall Survival Overall Response Rate Duration of response Disease Control Rate Duration of response during maintenance phase Safety Quality of Life	—

Countries

Japan

Contacts

Public ContactHiroomi OGAWA

Gunma University Graduate School of Medicine Department of Thoracic and Visceral Organ Surgery

hiroomio@gmail.com027-220-8245

Outcome results

None listed

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