Multicenter Phese II Study of Optimal-XELOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral capecitabin plus Bevacizumab Maintenance Therapy in Advanced Colorectal Cancer

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000006478
• Lead Sponsor: Chubu Clinical Oncology Group (CCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-05
• Study Completion: 2015-09-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Previous history of severe drug-induced allergy (2)Brain metastasis (3)Cerebrovascular disease or its symptoms within 1 year. (4)Massive pleural effusion or ascites that required drainage. (5)History of active double cancer. (6)Previous history of thoromboembolitic disease, or necessity for antithrombotic drug. (7)Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. (8)History of gastrointestinal perforation within 1 year. (9)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy. (10)Severe renal failure or urinary protein (more than 2+). (11)Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). (12)Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (13)Interstitial lung disease or pulmonary fibrosis. (14)Uncontrolled infection. (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)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (17)Not appropriate for the study at the physician's assessment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall response rate, Overall survival, Duration of disease control, Reintroduction rate of XELOX+bavacizumab therapy, Safety