Status:
UNKNOWN
IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer
Lead Sponsor:
Karen-Lise Garm Spindler
Conditions:
Colorectal Cancer
Circulating Tumor DNA
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 colorect...
Detailed Description
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' ...
Eligibility Criteria
Inclusion
- Surgically removed Adenocarcinoma of the colon or rectum
- Pathologically stage I or II disease, and radical resection
- Detectable ctDNA in two weeks postoperative plasma sample
- No indication for adjuvant chemotherapy according to DCCG guidelines (website)
- Age at least 18 years
- ECOG performance status 0-2
- Clinically eligible for adjuvant chemotherapy at investigators decision.
- Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and Calculated or measured renal glomerular filtration rate at least 30 mL/min)
- Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable •
- Written and verbally informed consent
Exclusion
- Radiological evidence of distant metastasis, by CT- chest and abdomen
- Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
- Previous treatment with 5FU or oxaliplatin
- Neuropathy NCI grade \> 1
- Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
- Pregnant (positive pregnancy test) or breast feeding women
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03748680
Start Date
October 1 2018
End Date
October 1 2025
Last Update
February 25 2022
Active Locations (4)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Aarhus University Hospital
Aarhus, Denmark, 8000
3
Herlev Hospital
Herlev, Denmark
4
Odense University Hospital
Odense, Denmark