Safety and efficacy of FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab as second line Therapy in Advanced colorectal Cancer previously treated with bevacizumab.

Safety and efficacy of FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab as second line Therapy in Advanced colorectal Cancer previously treated with bevacizumab. - JSWOG0901

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002378

Enrollment

Registered

2009-08-28

Start date

2009-01-01

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

advanced colorectal cancer

Interventions

FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab is treated until progression.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) disease progression (PD) determined via clinical and/or radiographic assessment after chemotherapy with bevacizumab as 1st line (PD according to RECIST criteria/with measurable lesions) (2) colorectal cancer, cytologically and/or histrogically (3) witten informed consents (4) age: 20-75 years old (5) Performance Status(ECOG):0-1 (6) Life expectancy estimated >= 3 months (7) Sufficient organ functions

Exclusion criteria

Exclusion criteria: (1) Administering transfusion/hematopoietic factor or antithrombotic drug within 14 days (2) Serious renal complications (3) Serious drug hypersensitivity or a history of drug allergy (4) Peripheral neuropathy (5) Active concomitant malignancy (6) Active infections (7) High blood pressure and diabetic that cannot be controlled (8) symptomatic or asymptomatic but treated heart disease (9) interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema (10) Traumatic fracture of unrecovery (11) history of mental disturbances or cerebrovascular accident (12) Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer (13) Current or previous (within one year) history of GI perforation (14) Pleural effusion, peritoneal fluid and pericardial fluid (15) Symptomatic brain metastasis (16) uncontrolled diarrhea (17) Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week (18) Anti-platelets therapy (including aspirin and NSAIDS) (19) Need to treatment with atazanavir sulfate (20) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers (21) bleeding tendency(including hemoptysis) or coagulation disorder (22) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
.Overall survival from first line .Second progression free survival (progression free survival from first line) .Response rate .Time to treatment failure .Safety	—

Countries

Japan

Contacts

Public ContactSatoshi Ikeda

Hiroshima University Department of Endoscopic Surgery and Surgical Science,

082-257-5222

Outcome results

None listed

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