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

Phase 3

Active, not recruiting

• Conditions: Colon Cancer
• Interventions: Drug: Capecitabine; Drug: Oxaliplatin

• Registration Number: NCT01918527
• Lead Sponsor: Vejle Hospital

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 available

Study Timeline

• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-07
• Study Start: 2013-09
• Primary Completion: 2023-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B, Neoadjuvant chemotherapy	Oxaliplatin	3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
A, Conventional treatment	Oxaliplatin	Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
A, Conventional treatment	Capecitabine	Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
B, Neoadjuvant chemotherapy	Capecitabine	3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.

Primary Outcome Measures

Name	Time	Method
Two-year disease free survival	2 years after completed study treatment

Secondary Outcome Measures

Name	Time	Method
Rate of patients fulfilling the criteria for adjuvant chemotherapy	6, 12, 18, and 24 months after completed study treatment

Trial Locations

Locations (9)

Vejle Hospital; 🇩🇰 Vejle, Denmark

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Hilleroed Hospital; 🇩🇰 Hillerød, Denmark

Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Sygehus Sønderjylland; 🇩🇰 Sønderborg, Denmark