A Phase 2 interventional study of Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy and Intensified Follow-up Schedule in Colorectal Cancer, Circulating Tumor DNA and Adjuvant Chemotherapy, sponsored by Karen-Lise Garm Spindler. Recruiting at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by Karen-Lise Garm Spindler · Phase 2, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 64 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Karen-Lise Garm Spindler is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Intensified follow-up schedule
Other: Intensified Follow-up Schedule
Adjuvant chemotherapy + intensified follow-up schedule
Drug: Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy
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.
DFS
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
Plan to share: No
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Karen-Lise Garm Spindler