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OPTIMIzation of Treatment SElection and Follow up in Oligometastatic Colorectal Cancer

RECRUITINGPhase 2Sponsored by Karen-Lise Garm Spindler
Actively Recruiting
PhasePhase 2
SponsorKaren-Lise Garm Spindler
Started2021-10-25
Est. completion2027-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

CancerColorectal CancerMetastatic Cancer

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