About this trial
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.
Eligibility criteria
Qualifiers
Resected colon cancer stage II, OR Resected rectal cancer stage II, if there was no indication for radiotherapy (i.e. due to the localisation in the upper third of the rectum ), so that the treatment follows the recommendations for colon cancer. Patients, in whom the tumour stage is not yet know, can be enrolled into the screening.
Signed informed consent for the screening Phase
Resected colon cancer stage II, OR resected rectal cancer stage II, if there was no indication for radiotherapy (i.e. due to the localisation in the upper third of the rectum), so that the treatment follows the recommendations for colon cancer.
Known microsatellite or mismatch repair status
Disqualifiers
Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy
Patients, who have an obvious contra-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbidity, active second cancer or age). It should be considered that patients with an age of more than 75 years frequently not fulfil criteria for adjuvant chemotherapy.
R1- or R2-status (patients with [still] unknown R-status can be screened)
Trial design
Treatments tested in this trial
- Capecitabine