Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11

Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11 - Randomized Phase II study of Bevacizumab with SOX versus Bevacizumab with XELOX as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1 and CPT-11

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006911

Enrollment

Registered

2011-12-19

Start date

2012-01-01

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

Metastatic colorectal cancer

Interventions

SOX+Bevacizumab Bevacizumab 7.5mg/kg/triweekly L-OHP 130 mg/m2/triweekly TS-1 80,100,120 mg/twice/day 1-14, following one week off XELOX+Bevacizumab Bevacizumab 7.5mg/kg/triweekly L-OHP 130 mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with histologically proven colorectal cancer (2) Metastatic colorectal cancer (3) Age over 20 (4) ECOG Performance Status (PS) 0-1 (5) A measurable or evaluable lesion is confirmed with objective documents such as CT, MRI and the X-ray check within 30th before registration (a measurable lesions in RECIST criteria is unnecessary) (6) Metastatic colorectal cancer which has prior therapy of S-1 and CPT-11 (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 (9) Life expectancy of more than 3 months (10) Written informed consent

Exclusion criteria

Exclusion criteria: (1) History of severe allergy (2) Pregnant or lactating women or women of childbearing potential (3) Severe infectious disease (4) Serious complication (e.g. interstitial pneumonia or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) (5) Comorbidity or history of heart failure (6) Peptic ulcers (7) Peripheral neuropathy (8) Severe diarrhea (9) Massive ascites or pleural effusion requiring treatment (10) Metastasis to the CNS (11) Current or previous (within the last 6 months) history of GI perforation (12) Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia or hemoptysis (=> 2.5ml) (13) Any surgical treatments within 28 days (14) Evidence of bleeding diathesis or coagulopathy (15) Ongoing treatment with anticoagulant or aspirin (> 325mg/day) (16) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (17) Under coutinuous steroid administration (18) Administration contraindication of L-OHP, Bevacizumab, S-1 or Capecitabine (19) Presence of severe colorectal stricture (20) Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
Response rate (RR) Time to treatment failure (TTF) Overall Survival (OS) Safety profile	—

Countries

Japan

Contacts

Public ContactToshiki Masuishi

Tsuchiura kyodo general hospital Department of Gastroenterology

Outcome results

None listed

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