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

October 5, 2023 updated by: Vejle Hospital

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

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalborg, Denmark
        • Aalborg University Hospital
      • Copenhagen, Denmark
        • Rigshospitalet
      • Herlev, Denmark
        • Herlev Hospital
      • Hillerød, Denmark
        • Hilleroed Hospital
      • Roskilde, Denmark
        • Roskilde Hospital
      • Sønderborg, Denmark
        • Sygehus Sønderjylland
      • Vejle, Denmark
        • Vejle Hospital
      • Bergen, Norway
        • Haukeland University Hospital
      • Göteborg, Sweden
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
2 years after completed study treatment

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
6, 12, 18, and 24 months after completed study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

August 6, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimated)

August 7, 2013

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

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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