Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: A, Conventional treatment Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated. |
Drug: Capecitabine
Orally on days 1-14: 2000 mg/m2/day q3w
Drug: Oxaliplatin
Intravenously on day 1: 130 mg/m2 q3w
|
| Other: B, Neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated. |
Drug: Capecitabine
Orally on days 1-14: 2000 mg/m2/day q3w
Drug: Oxaliplatin
Intravenously on day 1: 130 mg/m2 q3w
|
Outcome Measures
Primary Outcome Measures
- Two-year disease free survival [2 years after completed study treatment]
Secondary Outcome Measures
- Rate of patients fulfilling the criteria for adjuvant chemotherapy [6, 12, 18, and 24 months after completed study treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan.
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Age ≥ 18 years
-
PS 0-2.
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Hematology ANC ≥1.5x109/l. Thrombocytes ≥ 100x109/l.
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Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value
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Consent to translational research
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Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
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Written and orally informed consent.
Exclusion Criteria:
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Patients with distant metastases.
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Acute operation
-
Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion.
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Active, serious infection or other serious disease.
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Peripheral neuropathy NCI grade > 1
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Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri.
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Other investigational treatment within 30 days prior to treatment start.
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Hypersensitivity to one or more of the active or auxiliary substances.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aalborg University Hospital | Aalborg | Denmark | ||
| 2 | Rigshospitalet | Copenhagen | Denmark | ||
| 3 | Herlev Hospital | Herlev | Denmark | ||
| 4 | Hilleroed Hospital | Hillerød | Denmark | ||
| 5 | Roskilde Hospital | Roskilde | Denmark | ||
| 6 | Sygehus Sønderjylland | Sønderborg | Denmark | ||
| 7 | Vejle Hospital | Vejle | Denmark | ||
| 8 | Haukeland University Hospital | Bergen | Norway | ||
| 9 | Sahlgrenska University Hospital | Göteborg | Sweden |
Sponsors and Collaborators
- Vejle Hospital
Investigators
- Study Chair: Anders Jakobsen, DMSc, Vejle Hospital, Vejle, Denmark
- Principal Investigator: Henrik Jensen, MD, PhD, Vejle Hospital, Vejle, Denmark
- Principal Investigator: Olav Dahl, MD, Haukeland University Hospital, Bergen, Norway
- Principal Investigator: Göran Carlsson, MD, Sahlgrenska University Hospital, Gothenburg, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NeoCol