Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A, Conventional treatment<br>Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated. | Drug: Capecitabine<br>* Orally on days 1-14: 2000 mg/m2/day q3w<br>Drug: Oxaliplatin<br>* Intravenously on day 1: 130 mg/m2 q3w<br>|
| Other: B, Neoadjuvant chemotherapy<br>3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated. | Drug: Capecitabine<br>* Orally on days 1-14: 2000 mg/m2/day q3w<br>Drug: Oxaliplatin<br>* Intravenously on day 1: 130 mg/m2 q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-year disease free survival |  | 2 years after completed study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients fulfilling the criteria for adjuvant chemotherapy |  | 6, 12, 18, and 24 months after completed study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally advanced colon cancer, Neoadjuvant chemotherapy