Liver resection after chemotherapy for liver only metastasis from colorectal cancer

UMIN ID: UMIN000002101

Registered date:22/06/2009

Basic Information

• Health condition(s) or Problem(s) studied: Liver metastasis of colorectal cancer
• Date of first enrollment: 2009/04/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Chemotherapy with modified FOLFOX6 plus BV(bevacizumab). Treatment repeats every 14 days for up to 6 courses (5 courses for BV) in the absence of disease progression or unacceptable toxicity. Liver resection (if possible, 4 to 8 weeks after modified FOLFOX6 plus BV)

Outcome(s)

• Primary Outcome: Curative resection rate (R0 resection rate) [in all subjects]
• Secondary Outcome: 1) Resection rate, Curative resection rate (R0 resection rate) [in all resected subjects], Conversion rate of nonresectable disease to resectable disease in subjects with nonresectable liver metastasis Conversion rate of resectable disease to nonresectable disease in subjects with resectable liver metastasis 2) Safety of liver resection after chemotherapy with modified FOLFOX6 plus BV 3) Safety and efficacy of modified FOLFOX6 plus BV 4) Recurrence rate, Overall survival, Progression-free survival (in subjects with resectable liver metastasis), Relapse-free survival (in subjects with curative liver resection)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: (1) Transfusion or blood product or growth factor such as G-CSF less than 7 days prior to entry (2) Prior severe drug allergy (3) Radiotherapy less than 4 weeks prior to entry (4) Chronic daily treatment with anti-platelet drug such as high dose aspirin (more than 325mg/day) or other NSAID (temporary use of NSAIDs for cancer pain are permitted) (5) Presence of cerebrovascular disease or symptoms less than 1 year prior to entry (6) Presence of uncontrolled pleural effusion or ascites (7) Presence of cardiac effusion (8) Presence of active infection (9) Presence of viral hepatitis (10) Other active malignancy or multiple colorectal cancers (11) Severe postoperative complications(e.g. postoperative infection, anastomotic dehiscence,or paralytic ileus) (12) Uncontrolled co-mobility, such as hypertension, diabetes, arrhythmia, or other medical conditions (13) Hemorrhage/bleeding,paralytic ileus, obstruction, or ulceration of gastrointestinal tract (14) Perforation of gastrointestinal tract less than 1 year prior to entry (15) Grade 2 diarrhea or sensory neuropathy (16) Chronic systemic treatment of corticosteroid (17) Phenytoin, Warfarin potassium, or flucytosin administration (18) Surgery, biopsy with skin incision, or traumatic injury with suture less than 4 weeks prior to entry (19) Nursing or pregnant females, or females or males with female partners who are planning to pregnancy (20) Participation in other clinical trial (21) Any other serious medical condition that would preclude study treatment

Related Information

• Primary Sponsor: Tokyo Medical & Dental University
• Source(s) of Monetary Support: Foundation for Biomedical Research and Innovation