Actively Recruiting
Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation (CIRCULATE) AIO-KRK-0217
Led by Technische Universität Dresden · Updated on 2020-08-06
4812
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating adjuvant therapy options for patients with stage II colon cancer who test positive for circulating tumour DNA (ctDNA) after surgery. The study compares disease-free survival between those receiving capecitabine chemotherapy and those under follow-up without chemotherapy. This phase 3, multicenter, randomized controlled trial also includes patients with rectal cancer not requiring radiation due to tumor location, aiming to improve treatment decisions based on ctDNA status. After surgery, patients are screened with tumor tissue and blood tests to detect ctDNA and other genetic markers. Those positive for ctDNA and without microsatellite instability are randomized to receive either capecitabine chemotherapy alone or with oxaliplatin (based on investigator choice) or to follow-up without chemotherapy. ctDNA-negative patients are randomized to follow-up within the study or routine follow-up outside the trial. Chemotherapy lasts approximately 3 to 6 months depending on regimen chosen. Participants undergo regular follow-up visits and assessments to monitor disease recurrence and overall health. The primary outcome is disease-free survival measured after about 60 months. Secondary outcomes include overall survival, sites of metastases, and frequency of adverse events related to chemotherapy. The study uses quadruple blinding so that neither patients nor investigators know ctDNA status or treatment group, ensuring unbiased results. Total participation duration may extend up to five years for long-term monitoring.
CONDITIONS
Brief Title
Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Resected colon cancer stage II, or resected rectal cancer stage II without indication for radiotherapy (tumour located in upper third of rectum)
- Signed informed consent for screening phase
- Known microsatellite or mismatch repair status for randomized phase
- Confirmation that the circulating tumour DNA result is available
- Signed second informed consent for randomized phase
You will not qualify if you...
- Known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
- Clinical high risk situations requiring adjuvant chemotherapy
- Obvious contraindication for adjuvant chemotherapy (e.g. poor performance status, comorbidities, active second cancer, advanced age >75 years)
- R1 or R2 resection status
- Logistical reasons making randomisation or chemotherapy unfeasible (travel distance, compliance)
- Age under 18 years
- Pregnant or breastfeeding patients
- Number of investigated lymph nodes less than 10 for randomized phase
- WHO performance status 2 or higher
- Colon or rectal cancer at UICC stage III or IV
- Second cancer except certain low-risk types
- Contraindications to chemotherapy including low blood counts, liver enzyme elevations, low creatinine clearance
- Relevant comorbidities impacting prognosis (heart failure NYHA III/IV, coronary heart disease, diabetes with late sequelae)
- Organ, stem cell or bone marrow transplantation
- Known hypersensitivity to capecitabine
- Recent medication with brivudine, sorivudine or analogues
- Known dihydropyrimidine dehydrogenase deficiency
- Acute infections
- Known HIV or active hepatitis B or C infections
- Participation in another interventional medical treatment study within 4 weeks
- Neoadjuvant therapy before resection
- Women and men not willing to use effective contraception if randomized to chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 5 weeks after surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) before discharge or within 5 weeks after surgery
Duration - 1 day
Participants who meet eligibility criteria are randomized to treatment or follow-up after a baseline visit with a medical oncologist who confirms eligibility and consents participants for the randomized phase.
1 visit (in-person) 4 to 8 weeks after surgery
Duration - 3 to 6 months
Participants randomized to chemotherapy receive capecitabine alone or with oxaliplatin for adjuvant treatment lasting approximately 3 to 6 months.
Regular visits for chemotherapy administration and monitoring over 3 to 6 months
Duration - Up to 5 years
Participants randomized to follow-up or off study are monitored according to study protocol or routine clinical practice for disease status and safety.
Visits scheduled according to study protocol or routine care for up to 5 years
Trial Site Locations
Total: 1 location
1
Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik
Dresden, Saxony, Germany, 01307
Actively Recruiting
Research Team
G
Gunnar Folprecht, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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