Clinical trial NCT01918527: Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Official title: Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Colon Cancer
Keywords: Locally advanced colon cancer
Neoadjuvant chemotherapy
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Two-year disease free survival
timeFrame: 2 years after completed study treatment
Secondary outcomes:
measure: Rate of patients fulfilling the criteria for adjuvant chemotherapy
timeFrame: 6, 12, 18, and 24 months after completed study treatment
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Hillerød
country: Denmark
facility: Hilleroed Hospital
city: Roskilde
country: Denmark
facility: Roskilde Hospital
city: Sønderborg
country: Denmark
facility: Sygehus Sønderjylland
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Vejle Hospital, Vejle, Denmark
name: Anders Jakobsen, DMSc
role: STUDY_CHAIR
affiliation: Vejle Hospital, Vejle, Denmark
name: Henrik Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland University Hospital, Bergen, Norway
name: Olav Dahl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: Göran Carlsson, MD
role: PRINCIPAL_INVESTIGATOR
References: