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

NCT01918527 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Capecitabine

Orally on days 1-14: 2000 mg/m2/day q3w

DRUG

Oxaliplatin

Intravenously on day 1: 130 mg/m2 q3w

Sponsors & Collaborators

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Anders Jakobsen, DMSc · Vejle Hospital, Vejle, Denmark

  • Henrik Jensen, MD, PhD · Vejle Hospital, Vejle, Denmark

  • Olav Dahl, MD · Haukeland University Hospital, Bergen, Norway

  • Göran Carlsson, MD · Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2023-06-30
Completion
2026-06-30

Countries

  • Denmark
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918527 on ClinicalTrials.gov