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

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ClinicalTrials.gov Identifier: NCT01918527
Recruitment Status : Recruiting
First Posted : August 7, 2013
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Tracking Information
First Submitted Date  ICMJE August 6, 2013
First Posted Date  ICMJE August 7, 2013
Last Update Posted Date September 24, 2018
Actual Study Start Date  ICMJE September 2013
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
Two-year disease free survival [ Time Frame: 2 years after completed study treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01918527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
Rate of patients fulfilling the criteria for adjuvant chemotherapy [ Time Frame: 6, 12, 18, and 24 months after completed study treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Official Title  ICMJE Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • Drug: Capecitabine
    Orally on days 1-14: 2000 mg/m2/day q3w
  • Drug: Oxaliplatin
    Intravenously on day 1: 130 mg/m2 q3w
Study Arms  ICMJE
  • A, Conventional treatment
    Operation + 8 cycles of adjuvant chemotherapy, if indicated.
    Interventions:
    • Drug: Capecitabine
    • Drug: Oxaliplatin
  • B, Neoadjuvant chemotherapy
    3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
    Interventions:
    • Drug: Capecitabine
    • Drug: Oxaliplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2013)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Denmark,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01918527
Other Study ID Numbers  ICMJE NeoCol
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vejle Hospital
Study Sponsor  ICMJE Vejle Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Vejle Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP