NIPH Clinical Trials Search

UMIN ID: UMIN000002042

Registered date:05/06/2009

Phase II trial of mFOLFOX6/XELOX plus bevacizumab with oxaliplatin in a stop and go fashion in advanced metastatic colorectal cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced colorectal cancer
Date of first enrollment2009/06/01
Target sample size65
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)6 cycles of bi-weekly mFOLFOX6 plus bevacizumab regimen is followed by 6 cycles of bi-weekly sLV5FU2 plus bevacizumab regimen. Agter the 12 cycle treatment, 6 cycles of bi-weekly mFOLFOX6 plus bevacizumab regimen is re-administred. Or 4 cycles of Tri-weekly XELOX plus bevacizumab regimen is followed by 4 cycles of Trii-weekly Capacitabine plus bevacizumab regimen. After the 8 cycle treatment, 4 cycles of Tri-weekly XELOX plus bevacizumab regimen is re-administred.


Primary Outcomemedian prpgression free survival (PFS)
Secondary Outcomeresponse rate (RR), overall survival (OS), time to treatment failure (TTF), and incidence of neurotoxicity

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaExclusion criteria: 1. patient treated with blood transfusion, blood products or G-CSF within 7 days before registration. 2.patient who has or clinically suspicious for brain metastasis. 3. patient with a mental disorder or a history of a CNS disorder 4. patient with paresthesia 5. patient who need drainage of peritoneal, pleural or pericardial effusion. 6. double cancer 7. hypercalcemia (albumin-modified Ca value 12mg/dl or more). 8. poorly controlled diabetes mellitus. 9. proteinuria (grade 2 or more) 10. history of severe drug hypersensitivity or drug allergy 11. poorly controlled hypertension 12. obvious abnormality in ECG

Related Information


public contact
Name Chikashi Ishioka
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 9808575, Japan Japan
Telephone 022-717-8599
Affiliation Tohoku Clinical oncology, reserach and Education Society (T-CORE) Administration Office
scientific contact
Name Takashi Yoshioka
Address 2-2-2 IIda Nishi, Yamagata, 990-9585 , Japan Japan
Telephone 023-628-5222
Affiliation Yamagata University School of Medicine Division of clinical oncology