Evaluation of the efficacy of XELOX(L-OHP: 100mg/m2)+Bevacizumab for patient with metastatic or recurrent Colorectal Cancer as first-line chemotherapy

Evaluation of the efficacy of XELOX(L-OHP: 100mg/m2)+Bevacizumab for patient with metastatic or recurrent Colorectal Cancer as first-line chemotherapy - Evaluation of the efficacy of XELOX(L-OHP: 100mg/m2)+Bevacizumab for patient with metastatic or recurrent Colorectal Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007662

Enrollment

Registered

2012-04-09

Start date

2012-04-01

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

Capecitabine plus oxaliplatin(L-OHP: 100mg/m2) with bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proved colon cancer(adenocarcinoma) 2) Advanced or recurrent colorectal cancer that is not amenable to curative resection,and first line chemotherapy 3) >=20years-old 4) ECOG performance status 1-2 5) With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 6) Life expectancy greater than or equal to 3 months 7) Patient of possible oral ingestion 8) Adequate organ function 9) Patient who doesn't have cerebral metastasis 10)Written informed consent 11) Other conditions suitable for this study

Exclusion criteria

Exclusion criteria: 1) History of the serious hypersensitivity for Fluorouracil , Levofolinate calcium,platinum or bevacizumab 2) History of adverse events related to DPD loss 3) Active multiple Primary cancer within 5 years 4) Uncontrolled diarrhea 5) Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week 6) Complication of cerebrovascular disease or symptoms within 1 years 7) Administering antithrombotic drug within 10 days before enrollment 8) Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS) 9) Evidence of bleeding diathesis or coagulopathy 10) Symptom of colorectal obstruction 11) uncontrolled complication of peptic ulcer 12) Current or previous (within the last 1 year) history of GI perforation 13) Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry 14) Uncontrolled Hypertension 15) Uncontrolled Infection 16) Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers 17) Man who doesn't practice birth control 18) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Progression free survival, Overall Survival, 1-year survival rate, Disease control rate, Dose Intensity, Safety	—

Countries

Japan

Contacts

Public ContactTsunekazu Mizushima

Osaka University Graduate School of Medicine Department of Surgery

tmizushima@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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