A open label 1:1 randomized phase II exploratory study investigating adjuvant therapy in patients with molecular biologically detectable residual disease after primary resection for localized colorectal tumors.
The main clinical hypothesis is that patients having undergone radical resection from CRC do not present with detectable tumor DNA in the plasma, whereas patients with detectable tumor DNA two weeks' post surgery have residual microscopic disease, and consequently a high risk of diseases recurrence which can be prevented with adjuvant chemotherapy. The primary aim of the present study is to investigate - in a randomized trial - if use of standard adjuvant chemotherapy therapy improves the disease free survival in patients with molecular biological residual disease where adjuvant chemotherapy is not standard treatment . Secondary aims include investigating molecular biological response to adjuvant chemotherapy in patients with post-operative ctDNA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Six months of adjuvant combination chemotherapy with Capox (or FOLFOX) Patients will receive adjuvant chemotherapy with eight cycles of CAPOX (oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d. days 1-14, repeated every 3 weeks. (Patients with an ileostomy are only eligible for FOLFOX and will be treated with 12 cycles of FOLFOX (oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every second weeks)
Close monitoring with Imaging during follow-up Patients included in this trial will undergo intensified follow-up with CT-chest and abdomen every four months after surgery for the first 2 years, then every 6 months for 1 years and finally once yearly for the last 2 years up to 5 years follow-up is completed.
Aalborg University Hospital
Aalborg, Denmark
RECRUITINGAarhus University Hospital
Aarhus, Denmark
RECRUITINGHerlev Hospital
Herlev, Denmark
RECRUITINGDFS
Disease free survival
Time frame: 3 years
Molecular biological response
Molecular biological response at 6 months
Time frame: 6 months
MB-DFS
Molecular biological disease free survival at 1 year
Time frame: 1 year
TT-MBR
Time to molecular biological recurrence
Time frame: 3 years
TTR
Time to radiological recurrence
Time frame: 3 years
LRR
Local recurrence rate
Time frame: 3 years
DRR
Distant recurrence rate
Time frame: 3 years
OS
Overall survival
Time frame: 5 years
TR
Translational research exploratory
Time frame: 3 years
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Odense University Hospital
Odense, Denmark
RECRUITING