Actively Recruiting
Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation
Led by Technische Universität Dresden · Updated on 2020-08-06
4812
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The CIRCULATE study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. The primary aim of the study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine.
CONDITIONS
Official 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 if no radiotherapy is indicated due to tumor location
- Signed informed consent for the screening phase
- Known microsatellite or mismatch repair status
- Confirmation that the circulating tumour DNA (ctDNA) result is available
- Signed second informed consent for the randomised phase
You will not qualify if you...
- Known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
- Clinical high-risk situation requiring adjuvant chemotherapy
- Contraindication for adjuvant chemotherapy due to performance status, comorbidities, active second cancer, or age (often over 75 years)
- Incomplete tumor resection status (R1 or R2)
- Infeasibility of randomisation or chemotherapy due to logistics or compliance
- Age under 18 years
- Pregnant or breastfeeding
- Number of investigated lymph nodes fewer than 10
- WHO performance status 2 or higher
- Colon or rectal cancer stage III or IV
- Second cancer except certain low-risk or treated cancers
- Blood count or liver/kidney function abnormalities incompatible with chemotherapy
- Comorbidities affecting prognosis such as severe heart failure or coronary disease
- 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 infection or active hepatitis B or C
- Participation in another interventional medical treatment study within 4 weeks before randomisation
- Neoadjuvant therapy before surgery
- Women of childbearing potential and men with partners of childbearing potential unwilling to use effective contraception if randomised to chemotherapy
AI-Screening
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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.
CONTACT
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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