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EU CTIS ID: 2023-509814-12-00
What this study is testing
The primary aim of the present study is to investigate - in a randomized trial - the clinical utility of circulating tumor DNA analysis to guide treatment decisions in oligometastatic colorectal cancer
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Radical intended treatment for metastatic spread from colorectal cancer, by resection, RFA, SBRT (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)
- No evidence of further disease based on pre-treatment work-up according to standard of care
- Age at least 18 years
- ECOG 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 ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/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)
You likely can't join if
- Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1
- Other malignant tumour 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 fluoropyrimidine, leucovorin, oxaliplatin or irinotecan
See the full eligibility criteria
- Radical intended treatment for metastatic spread from colorectal cancer, by resection, RFA, SBRT (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC)
- No evidence of further disease based on pre-treatment work-up according to standard of care
- Age at least 18 years
- ECOG 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 ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/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
- Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1
- Other malignant tumour 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 fluoropyrimidine, leucovorin, oxaliplatin or irinotecan
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.