- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01918527
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Aalborg, Denmark
- Aalborg University Hospital
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Copenhagen, Denmark
- Rigshospitalet
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Herlev, Denmark
- Herlev Hospital
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Hillerød, Denmark
- Hilleroed Hospital
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Roskilde, Denmark
- Roskilde Hospital
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Sønderborg, Denmark
- Sygehus Sønderjylland
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Vejle, Denmark
- Vejle Hospital
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Bergen, Norway
- Haukeland University Hospital
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Göteborg, Sweden
- Sahlgrenska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A, Conventional treatment
Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
|
Orally on days 1-14: 2000 mg/m2/day q3w
Intravenously on day 1: 130 mg/m2 q3w
|
Other: B, Neoadjuvant chemotherapy
3 cycles of neoadjuvant chemotherapy + operation.
Adjuvant chemotherapy only if indicated.
|
Orally on days 1-14: 2000 mg/m2/day q3w
Intravenously on day 1: 130 mg/m2 q3w
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Two-year disease free survival
Time Frame: 2 years after completed study treatment
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2 years after completed study treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients fulfilling the criteria for adjuvant chemotherapy
Time Frame: 6, 12, 18, and 24 months after completed study treatment
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6, 12, 18, and 24 months after completed study treatment
|
Collaborators and Investigators
Sponsor
Investigators
- 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 Chair: Anders Jakobsen, DMSc, Vejle Hospital, Vejle, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- NeoCol
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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