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

NCT01918527 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: NeoCol
• Study Type: interventional
• Target: 250
• Locations: 3 countries
• Sites: 9

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.

Conditions

Colon Cancer

Keywords

Locally advanced colon cancer; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Two-year disease free survival

  2 years after completed study treatment

Secondary Outcomes (1)

• Rate of patients fulfilling the criteria for adjuvant chemotherapy

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

Study Arms (2)

A, Conventional treatment

OTHER

Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.

Drug: Capecitabine; Drug: Oxaliplatin

B, Neoadjuvant chemotherapy

OTHER

3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.

Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Capecitabine DRUG

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

A, Conventional treatment; B, Neoadjuvant chemotherapy

Oxaliplatin DRUG

Intravenously on day 1: 130 mg/m2 q3w

A, Conventional treatment; B, Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with distant metastases.
• Acute operation
• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (9)

Aalborg University Hospital

Aalborg, Denmark

Location

Rigshospitalet

Copenhagen, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Hilleroed Hospital

Hillerød, Denmark

Location

Roskilde Hospital

Roskilde, Denmark

Location

Sygehus Sønderjylland

Sønderborg, Denmark

Location

Vejle Hospital

Vejle, Denmark

Location

Haukeland University Hospital

Bergen, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (1)

• Jensen LH, Kjaer M, Diness LV, Hollander NH, Rahr HB, Pfeffer F, Larsen FO, Lindebjerg J, Rafaelsen SR, Hansen TF, Timm S, Loes IM, Gogenur I, Zitnjak D, Andersen F, Petersen LN, Lindskog EB, Poulsen LO, Dahl O. Neoadjuvant Chemotherapy vs Upfront Surgery in Patients With Locally Advanced Colon Cancer: A Randomized Clinical Trial. JAMA Surg. 2026 Mar 4. doi: 10.1001/jamasurg.2026.0085. Online ahead of print.

  PMID: 41779406 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Anders Jakobsen, DMSc

  Vejle Hospital, Vejle, Denmark

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 7, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

SE (1); DK (7); NO (1)