A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy

A Phase II Study of Bi-weekly XELOX with Bevacizumab for patient with Metastatic Colorectal Cancer as first-line chemotherapy - Bi-weekly XELOX with Bevacizumab

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010259

Enrollment

Registered

2013-03-17

Start date

2013-03-18

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

advanced and/or recurrent colorectal cancer

Interventions

XELIRI plus bevacizumab therapy /Capecitabine

2,000 mg/m2 day1-8(orally, day1 after dinner

day8 after breakfast) /Oxaliplatin 85 mg/m2 day1 /Bevacizumab: 5mg/kg day 1 The treatment is repeated every two weeks until disease progression or severe toxicity

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Written informed consent after the explanation of the content of the examination (2) Age of 20 years or older (3) ECOG PS 0-1 (4) Life expectancy more than 3 months (5) Histopathologically confirmed colorectal cancer (6) Measurable or evaluable disease (RECIST ver.1.1) (7) Metastatic colorectal cancer which has non prior therapy (8)Adequate organ functions

Exclusion criteria

Exclusion criteria: (1) Severe renal function disorder (2) History of serious drug hypersensitivity or a history of drug allergy (3) History of active double cancer within 5 years (4) Active infections (5) Distinctly abnormal ECG or cardiovascular disease (6) Cpmplication of thromboembolism,severe pulmonary disease(interstitial pneumonia, pulmonary fibrosis, mild Emphysema) "(7) complication of GI perforation or hemorrhage ,Paresis of intestine or intestinal obstruction " (8) Massive pleural effusion or ascites that required drainage (9) Brain metastasis (10) Complication of mental disorder,CNS disease, cerebrovascular disease. (11) Uncontrollable hypertension or diabetes mellitus (12) Uncontrollable diarrhea "(13) Patients with non-healing wounds,or surgery (thoracotomy, laparotomy) within 4 weeks " (14) Non-healing fracture (15) Bleeding diathesis or receiving anticoagulant drug(except Aspirin under 325mg/day) (16) Pregnant or lactating woman (17) Peripheral neuropathy (18) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
overall survival Time to Treatment Failur Response Rate Disease Control Rate Relative Dose Intensity Rate of Adverse Event safety	—

Countries

Japan

Contacts

Public ContactShoichi Hazama

Yamaguchi University Graduate School of Medicibe Digestive surgery and surgical oncology

hazama@yamaguchi-u.ac.jp+81-836-22-2264

Outcome results

None listed

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