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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01918527). StuddyBuddy aggregates publicly available trial information.