Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer

Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer - Multicenter randomized phase ll study of XELOX plus bevacizumab or XELIRI plusbevacizumab as first-line chemotherapy for metastatic or recurrent colorectal cancer(CCOG1201)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007547

Enrollment

100

Registered

2012-03-22

Start date

2012-03-01

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

XELOX plus bevacizumab therapy Bevacizumab 7.5mg/kg day1 Oxaliplatin 130mg/m2 day1 Capecitabin 2,000mg/m2/day day1-15 XELIRI plus bevacizumab therapy Bevacizumab 7.5mg/kg day1 Irinotecan 200mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histopathologically confirmed colorectal cancer (2)Unresectable and Untreated advanced colorectal cancer patients (3)Age of 20 years or older (4)ECOG performance status 0-1 (5)Measurable or evaluable disease (RECIST ver.1.1.) (6)Alife expectancy greater than 3 months (7)satisfactory oral feeding (8)Adequate organ function (9)Written informed concent

Exclusion criteria

Exclusion criteria: (1)Uncontrolled infection. (2)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (3)Previous history of thoromboembolitic disease,or necessity for antithrombotic drug. (4)Severe lung disease.(Interstitial lung disease or pulmonary fibrosis.) (5)Severe liver disease. (6)Severe renal failure. (7)Previous history of severe drug-induced allergy (8)Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. (9)History of gastrointestinal perforation within 1 year. (10)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.) (11)History of active double cancer. (12)Massive pleural effusion or ascites that required drainage. (13)Brain metastasis (14)Patients with psycho-neurological disease,central nervous system damage,cerebrovascular disorder (15)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week. (16)Patient with untreated traumatic bone fracture. (17)Diathesis of bleeding (history of hemoptysis,including cavitation and/or necrosis in lung metastasis confirmed by imaging),coagulopathy. (18) Systemic administration of antiplatelet drug (19)Patient who have peripheral nerve disorder (20)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (21)Not appropriate for the study at the physician's assessment.

Design outcomes

Primary

Measure	Time frame
ORR; Overall response rate	—

Secondary

Measure	Time frame
PFS; Progression free survival DDC;Duration of disease control TTF; Time to treatment failure OS; Overall survival Safety	—

Countries

Japan

Contacts

Public ContactMiyuki Aoki

Chubu Clinical Oncology Group (CCOG) Data Center

norifumi@med.nagoya-u.ac.jp(81)52-744-2253

Outcome results

None listed

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