NCT04680260RecruitingPhase 2
OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer
OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer - a ctDNA Guided Phase II Randomized Approach
Source: ClinicalTrials.gov · Last updated 14 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 19 Oct 2020
- Start date
- 25 Oct 2021
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Karen-Lise Garm Spindler
- Diseases
- Colorectal cancer
- NCT number
- NCT04680260
- EU CT number
- 2023-509814-12-00
- EudraCT number
- 2020-004524-41
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 350
- From 25 Oct 2021 to the primary completion date, 1 Mar 2027
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with triple combination chemotherapy
Other illness
- 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
Other
- Radiological evidence of distant metastasis, by CT- chest, abdomen, and pelvis
- Pregnant (positive pregnancy test) or breast feeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Not yet recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Region Sjaelland Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
| Lillebaelt Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.