A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer.

A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer. - A phase II study of alternate-day administration of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination as first-line treatment in patients with metastatic colorectal cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020439

Enrollment

Registered

2016-01-05

Start date

2016-01-05

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

S-1 80-120 (mg/day) Monday, Wednesday, Friday, Sunday Leucovorin 50 (mg/day) Monday, Wednesday, Friday, Sunday Oxaliplatin 85 (mg/m2) day1 Bevacizumab 5 (mg/kg) day 1 every 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically proven adenocarcinoma of unresectable colorectal cancer (2) With measurable disease according to RECIST version1.1 (3) No prior chemotherapy (4) ECOG Performance Status of 0 or 1 (5) >=20 years old (6) Life expectancy of more than 3 months (7) Adequate oral intake (8) Adequate organ function (9) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Active multiple malignancy (2) History of severe drug-induced hypersensitivity (3) Symptomatic brain metastasis (4) Active infection (5) Interstitial pneumonia or pulmonary fibrosis (6) Serious complications (renal failure, liver failure, severe cardiac disease, uncontrolled diabetes, uncontrolled hypertension, ileus) (7) massive pleural, abdominal, or pericardial effusion (8) Administration of phenytoin or flucytosine (9) Systemic administration of steroid (10) Thromboembolism (grade 3 or higher) within 6 months before enrollment (11) Any major surgery or open biopsy within 4 weeks before scheduled date of treatment (14) Bleeding diathesis or tendency (13) Active peptic ulcer (14) History of gastrointestinal perforation within 1 year before enrollment (15) Clinically significant mental disorder (16) Positive for HBs antigen (17) Women who are pregnant or patients who are unwilling to avoid pregnancy (18) grade 2 or higher peripheral neuropathy (19) previous treatment with oxaliplatin (20) Patients who are inappropriate for the study in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Objective response rate as assessed by independent ragiologic review	—

Secondary

Measure	Time frame
Objective response rate as assessed by investigators Progression free survival Time to treatment failure Overall survival Disease control rate The efficacy according to RAS status R0 resection rate Safety Relative dose intensity	—

Countries

Japan

Contacts

Public ContactToshiki Masuishi

Aichi Cancer Center Hospital Department of Clinical Oncology

tmasuishi@aichi-cc.jp052-762-6111

Outcome results

None listed

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