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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01918527
Recruitment Status : Recruiting
First Posted : August 7, 2013
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Study Description
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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
Colon Cancer Drug: Capecitabine Drug: Oxaliplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Actual Study Start Date : September 2013
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025
Arms and Interventions
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Arm Intervention/treatment
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
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
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Primary Outcome Measures :
  1. Two-year disease free survival [ Time Frame: 2 years after completed study treatment ]

Secondary Outcome Measures :
  1. Rate of patients fulfilling the criteria for adjuvant chemotherapy [ Time Frame: 6, 12, 18, and 24 months after completed study treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918527


Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark
Contact: Mette N Yilmaz, MD       m.yilmaz@rn.dk   
Principal Investigator: Mette N Yilmaz, MD         
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Lone Nørgaard, MD       Lone.Noergaard.Petersen@regionh.dk   
Principal Investigator: Lone Nørgaard, MD         
Herlev Hospital Recruiting
Herlev, Denmark
Contact: Ole Larsen, MD       ole.larsen@regionh.dk   
Principal Investigator: Ole Larsen, MD         
Hilleroed Hospital Recruiting
Hillerød, Denmark
Contact: Kell Østerlind, MD       kell.oesterlind@regionh.dk   
Principal Investigator: Keld Østerlind, MD         
Roskilde Hospital Recruiting
Roskilde, Denmark
Contact: Jim S Larsen, MD       JSLA@regionsjaelland.dk   
Principal Investigator: Jim S Larsen, MD         
Sygehus Sønderjylland Recruiting
Sønderborg, Denmark
Contact: Daniela Zitnjak, MD       Daniela.Zitnjak@rsyd.dk   
Principal Investigator: Daniela Zitnjak, MD         
Vejle Hospital Recruiting
Vejle, Denmark
Contact: Anders Jakobsen, DMSc       anders.jakobsen@rsyd.dk   
Contact: Henrik Jensen, MD, PhD       lars.henrik.jensen@rsyd.dk   
Principal Investigator: Henrik Jensen, MD, PhD         
Sub-Investigator: John Ploen, MD         
Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Olav Dahl, MD       olav.dahl@helse-bergen.no   
Principal Investigator: Olav Dahl, MD         
Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden
Contact: Göran Carlssen, MD       goran.u.carlsson@vgregion.se   
Principal Investigator: Göran Carlsson, MD         
Sponsors and Collaborators
Vejle Hospital
Investigators
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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
More Information
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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01918527    
Other Study ID Numbers: NeoCol
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Keywords provided by Vejle Hospital:
Locally advanced colon cancer
Neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents