EUCTR2013-002363-26-SE
Active, not recruiting
Phase 1
eoadjuvant chemotherapy versus standard treatment in patients with locally advanced colon cancer - NeoCol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Colon cancer
- Sponsor
- Vejle Hospital
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically verified locally advanced T3 (ETI \> 5 mm) or T4 colon cancer assessed by CT scan.
- •Age \= 18 years
- •Hematology
- •ANC \=1\.5x10^9/l. Thrombocytes \= 100x10^9/l.
- •Biochemistry
- •Bilirubinemia \= 3 x upper normal level. ALAT \= 5 x upper normal value
- •Consent to translational research
- •Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
- •Written and orally informed consent.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •Patients with distant metastases.
- •Acute operation
- •Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) \= 1 year before inclusion.
- •Active, serious infection or other serious disease.
- •Peripheral neuropathy NCI grade \> 1
- •Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri.
- •Other investigational treatment within 30 days prior to treatment start.
- •Hypersensitivity to one or more of the active or auxiliary substances.
Outcomes
Primary Outcomes
Not specified
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