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Completed
NCT01918527
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Conditions: Colon Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 250
Sponsor: Vejle Hospital
Location: Aalborg University Hospital Aalborg
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 (adjuvant) chemotherapy.
Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.
Eligibility Criteria
Inclusion Criteria:
* 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 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.
Source: ClinicalTrials.gov (NCT01918527). StuddyBuddy aggregates publicly available trial information.