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OpenTrials
Active, Not Recruiting

NCT Number: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capecitabine

Drug

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

Oxaliplatin

Drug

Intravenously on day 1: 130 mg/m2 q3w

Primary outcomes

  1. Two-year disease free survival

    Time frame: 2 years after completed study treatment

Secondary outcomes

  1. Rate of patients fulfilling the criteria for adjuvant chemotherapy

    Time frame: 6, 12, 18, and 24 months after completed study treatment

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2023
Study completion
2026
First posted
Aug 7, 2013
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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