RecruitingPhase 2NCT04680260

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


Sponsor

Karen-Lise Garm Spindler

Enrollment

350 participants

Start Date

Oct 25, 2021

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the best way to monitor and treat people with colorectal cancer (bowel cancer) that has spread to a limited number of other spots in the body — called "oligometastatic" disease. After local treatments like surgery or radiation wipe out those spots, researchers want to know if chemotherapy afterward helps prevent the cancer from coming back. **You may be eligible if...** - You are 18 or older - You have colorectal cancer that spread to a limited number of sites and those sites were treated with surgery, ablation, or radiation - Scans show no remaining signs of cancer after treatment - Your blood counts, liver, and kidney function are in an acceptable range - You are physically able to handle combination chemotherapy (performance status 0–2) **You may NOT be eligible if...** - Scans show cancer has spread further - You are too frail or have too many other health problems for intensive chemotherapy - You have significant nerve damage (neuropathy) - You had another cancer in the last 5 years (except certain skin cancers) - You are pregnant or breastfeeding - You have known allergies to the study chemotherapy drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard 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.

OTHERCirculating 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.


Locations(2)

Department of Oncology, Aarhus University Hospital

Aarhus N, Denmark

Department pf Oncology, Vejle Hospital

Vejle, Denmark

View Full Details on ClinicalTrials.gov

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NCT04680260


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