Status:
RECRUITING
OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer
Lead Sponsor:
Karen-Lise Garm Spindler
Collaborating Sponsors:
Vejle Hospital
Zealand University Hospital
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
Detailed Description
An open label 1:1 randomized phase II exploratory study investigating use of ctDNA-guided adjuvant chemotherapy compared to standard of care (SOC) after local treatment for metastatic colorectal cance...
Eligibility Criteria
Inclusion
- Radical intended treatment for metastatic spread from CRC, by resection, radiofrequency ablation, stereotactic body radiation therapy (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC)
- No evidence of further disease based on pre-treatment work-up according to SOC
- Age at least 18 years
- Eastern Cooperative Oncology Group performance status 0-2
- Clinically eligible for adjuvant triple CT 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, abdomen, and pelvis
- Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy
- Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 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
- Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine
Key Trial Info
Start Date :
October 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04680260
Start Date
October 25 2021
End Date
March 1 2030
Last Update
August 14 2024
Active Locations (2)
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1
Department of Oncology, Aarhus University Hospital
Aarhus N, Denmark, 8200
2
Department pf Oncology, Vejle Hospital
Vejle, Denmark, 7100