Colon Cancer
Conditions
Keywords
Locally advanced colon cancer, Neoadjuvant chemotherapy
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 (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.
Interventions
DRUGCapecitabine
Orally on days 1-14: 2000 mg/m2/day q3w
DRUGOxaliplatin
Intravenously on day 1: 130 mg/m2 q3w
Sponsors
Vejle Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year disease free survival | 2 years after completed study treatment |
Secondary
| Measure | Time frame |
|---|---|
| Rate of patients fulfilling the criteria for adjuvant chemotherapy | 6, 12, 18, and 24 months after completed study treatment |
Countries
Denmark, Norway, Sweden
Contacts
STUDY_CHAIRAnders Jakobsen, DMSc
Vejle Hospital, Vejle, Denmark
PRINCIPAL_INVESTIGATORHenrik Jensen, MD, PhD
Vejle Hospital, Vejle, Denmark
PRINCIPAL_INVESTIGATOROlav Dahl, MD
Haukeland University Hospital, Bergen, Norway
PRINCIPAL_INVESTIGATORGöran Carlsson, MD
Sahlgrenska University Hospital
Outcome results
None listed