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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01918527
• Other study ID #: NeoCol
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2013
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: February 2025
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• Capecitabine
Orally on days 1-14: 2000 mg/m2/day q3w
• Oxaliplatin
Intravenously on day 1: 130 mg/m2 q3w

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Hilleroed Hospital	Hillerød
Denmark	Roskilde Hospital	Roskilde
Denmark	Sygehus Sønderjylland	Sønderborg
Denmark	Vejle Hospital	Vejle
Norway	Haukeland University Hospital	Bergen
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Countries where clinical trial is conducted

Denmark,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-year disease free survival		2 years after completed study treatment
Secondary	Rate of patients fulfilling the criteria for adjuvant chemotherapy		6, 12, 18, and 24 months after completed study treatment