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Clinical Trials in Denmark / NCT04680260
Recruiting Phase 2

OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

NCT04680260 · tracked via the Priya Life Science Denmark tracker
Sponsor
Karen-Lise Garm Spindler
Phase
Phase 2
Started
2021-10-25
Last updated
2024-08-14

Condition(s) studied

Colorectal CancerMetastatic Cancer

Investigational drug(s) / intervention(s)

Standard of careCirculating tumor DNA guided treatment approach

Standard of care: Patients will be offered adjuvant chemotherapy according to standard of care. Follow up will be performed with imaging according to standard guidelines, equal to the experimental arm. Blood samples will be analyzed retrospectively to evaluate the ctDNA status.

Circulating tumor DNA guided treatment approach: Circulating tumor-marker positivity will lead to escalation with 6 months of intensified chemotherapy consisting of 4 months of FOLFOXIRI followed by 2 months of 5FU monotherapy. Circulating tumor-marker negativity will based on shared decision-making lead to de-escalation i.e. possibilities for observation in patients otherwise eligible for monotherapy or observation/monotherapy in patients, otherwise eligible for combination chemotherapy according to standard of care.

Study summary

A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Department of Oncology, Aarhus University Hospital Aarhus N Denmark Recruiting
Department pf Oncology, Vejle Hospital Vejle Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04680260 on ClinicalTrials.gov ↗ ← All trials in Denmark