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
Karen-Lise Garm Spindler
350 participants
Oct 25, 2021
INTERVENTIONAL
Conditions
Summary
A study investigating if analysis of circulating tumor DNA (ctDNA) can guide adjuvant treatment in patients with advanced colorectal cancer (CRC)
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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
Interventions
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-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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04680260