Phase II study of Cetuximab with mFOLFOX6 treatment in patients with previously untreated Rectal cancer
- Conditions
- Rectal Cancer
- Registration Number
- JPRN-UMIN000010791
- Lead Sponsor
- PO FMPC (Future Medicine Promoting Consortium)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Not provided
(1) History of serious drug hypersensitivity (2) Women who are pregnant,or wish to become pregnant or men who expect babies (3) Severe infectious disease (38degrees or higher) (4) Serious complications (5) Remarkably abnormal ECG,Clinically significant heart disease (6) Gastrointestinal ulceration or bleeding (7) Serious watery diarrhea (8) Uncontrolable pleural effusion or ascites requiring treatment (9) Cases with brain metastases or cases to doubt metastasis to brain from clinical manifestations (10) Current or previous (within the last 6months) history of GI perforation (11) Previous history of thrombosis,cerebra infarction,pulmonary infarction,hemoptysis (more than 2.5ml) and interstitial pneumonia (12) Cases were operated within 28days before entry (Except for inserting central venous catheters and reservoir) (13) Evidence of congenital bleeding diathesis or coagulopathy (14) Ongoing treatment with anticoagulant (15) Cases have active double cancer (disease free period is within five years) (16) Continuous systemic administration of corticosteroids (17) Patients judged inapproprite for this study by physicians
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate
- Secondary Outcome Measures
Name Time Method Adverse effect (AE) Progression free survival (PFS) Disease control rate (DCR) R0 resection rate Rate of surgery Time to Surgery (TTS)