Status:
ACTIVE_NOT_RECRUITING
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Lead Sponsor:
Vejle Hospital
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (...
Eligibility Criteria
Inclusion
- Histologically verified locally advanced T3 (ETI \> 5 mm) or T4 colon cancer assessed by CT scan.
- Age ≥ 18 years
- PS 0-2.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01918527
Start Date
September 1 2013
End Date
December 1 2025
Last Update
March 25 2025
Active Locations (9)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Rigshospitalet
Copenhagen, Denmark
3
Herlev Hospital
Herlev, Denmark
4
Hilleroed Hospital
Hillerød, Denmark