eoadjuvant chemotherapy versus standard treatment in patients with locally advanced colon cancer

Phase 1

• Conditions: Colon cancer; MedDRA version: 19.0Level: LLTClassification code 10009951Term: Colon cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002363-26-SE
• Lead Sponsor: Vejle Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-14
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of neoadjuvant chemotherapy in locally advanced colon cancer as estimated by disease free survival.;Secondary Objective: Not applicable;Primary end point(s): Two-year disease free survival.;Timepoint(s) of evaluation of this end point: Every 3 months the first year. <br>Every 6 months the second year.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1Rate of patients fulfilling the criteria for adjuvant chemotherapy.<br>2Overall survival (OS)<br>3Response to neoadjuvant chemotherapy as evaluated at the operation.;Timepoint(s) of evaluation of this end point: 1. At time of operation<br>2. Every 3 months the first year. Every 6 months the second year.