NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000996

Registered date:25/01/2008

A phase II study of oxaliplatin, folinic acid and 5-fluorouracil (modified FOLFOX-6) combination chemotherapy as adjuvant treatment after resection of liver metastases from colorectal cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedliver metastases of colorectal cancer
Date of first enrollment2006/07/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)To undergo modified folfox 6 regimen [5-fluorouracil 2.4 g/m2 (24-h continuous infusion), l-leucovorin 200 mg/m2 (2-h intravenous infusion), and oxaliplatin 85 mg/m2 (2-h intravenous infusion) every 2 weeks] for 24 weeks as adjuvant treatment after resection of liver metastases from colorectal cancer.

Outcome(s)

Primary Outcomedisease free survival side effect
Secondary Outcomeoverall survival

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria(1) Multiple cancer (2) Prebious history of severe drug-induced allergy (3) Given L-OHP within 6 months before this study (4) Active infection (5) Severe complication (6) Severe sensory disturbance (7) Pregnant (8) Disqualified by attendig doctor

Related Information

Contact

public contact
Name Kuniharu Yamamoto
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN Japan
Telephone 022-717-7208
E-mail kyama@surg1.med.tohoku.ac.jp
Affiliation Miyagi HBPCOG coordinating office Division of Hepato-Biliary Pancreatic Surgery. Tohoku University Graduate School of Medicine.
scientific contact
Name Michiaki Unno
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN Japan
Telephone 022-717-7208
E-mail kein_h11@surg1.med.tohoku.ac.jp
Affiliation Tohoku University Graduate School of Medicine Division of Hepato-Biliary Pancreatic Surgery