Multicenter Phase II sequential study of S-1/Oxaliplatin (SOX) and Bevacizumab as first line therapy followed by S-1/Irinotecan (IRIS) and Cetuximab as second line in patients with metastatic colorectal cancer. : A SOBIC study

Multicenter Phase II sequential study of S-1/Oxaliplatin (SOX) and Bevacizumab as first line therapy followed by S-1/Irinotecan (IRIS) and Cetuximab as second line in patients with metastatic colorectal cancer. : A SOBIC study - SOBIC study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004011

Enrollment

Registered

2010-08-20

Start date

2010-05-01

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

Metastatic Colorectal Cancer

Interventions

1st line SOX+BV 2nd line IRIS+Cmab IRIS+Bmab IRIS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with histologically proven colorectal cancer (2)Unresectable or recurrent colorectal camcer (3)Age >= 20 and =< 80 (4) ECOG performance status of 0,1. (5) Unresectable primary tumor or with one or more unresectable metatatic tumor Measurable or evaluable disease (measurable lesions in RECIST criteria is unnecessary) within 30 days before registration. (6)No prior chemotherapy or first recurrence with no chemotherapy for recurrent lesion.(without receiving adjuvant chemotherapy by 5FU only) (7)Ability of oral intake (8) Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data within two weeks before registration

Exclusion criteria

Exclusion criteria: (1) History of the serious hypersensitivity for Fluorouracil, oxaliplatin or bevacizumab (2) Pregnant or lactating women or women of childbearing potential. (3) Severe infectious disease (4) Serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) (5) Comorbidity or history of heart failure (6) Peptic ulcers (7) Severe dysesthesia or sensory abnormality with functional disorder (8) Severe diarrhea (9) Massive pleural effusion or ascites. (10) Obstruction or disorder on digestive tract due to peritoneal metastasis

Design outcomes

Secondary

Measure	Time frame
Receive rate of second line therapy, Overall survival, rate of KRAS mutation / wild type. Each evaluation of the first and second line respectively: response rate (RR), PFS, conversion rate of nonresectable to resectable and R0 resection ratio (R0-R), safety profile.	—

Primary

Measure	Time frame
Second PFS (progression-free survival)	—

Countries

Japan

Contacts

Public ContactMasafumi Noda

Hyogo College of Medicine Department of Surgery

ntomita@hyo-med.ac.jp0798-45-6370

Outcome results

None listed

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