NCT04680260 OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer
| NCT ID | NCT04680260 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Karen-Lise Garm Spindler |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2021-10-25 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 350 participants in total. It began in 2021-10-25 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Karen-Lise G Spindler, Professor
PRINCIPAL INVESTIGATOR
Department of Oncology, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT04680260 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04680260 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04680260 currently recruiting?
Yes, NCT04680260 is actively recruiting participants. Contact the research team at k.g.spindler@rm.dk for enrollment information.
Where is the NCT04680260 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Vejle, Denmark.
Who is sponsoring the NCT04680260 clinical trial?
NCT04680260 is sponsored by Karen-Lise Garm Spindler. The principal investigator is Karen-Lise G Spindler, Professor at Department of Oncology, Aarhus University Hospital. The trial plans to enroll 350 participants.
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