Tests blood DNA to guide treatment in colorectal cancer with spread
Tests blood tumor DNA to guide treatment in adults with colorectal cancer.
Plain-language title generated from the registry record
Registry title: OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer
Key facts
- Where
- Oslo, NorwaySee the site
- Phase
- Phase 2
Where in Norway
- Oslo University Hospital HFOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karen-Lise Garm Spindler
- Trial code
- NCT04680260EU 2023-509814-12-00
- Record updated
- 14 August 2024
- Original description
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)Read full original descriptionShow less
OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
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: 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; Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabine; Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis; Pregnant (positive pregnancy test) or breast feeding women.