BridgeMD
CIRCULATE
EU CTIS ID: 2023-506715-18-00
What this study is testing
The study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. To compare the disease free survival (DFS) in patients who are positive for ctDNA (ctDNApos) after the resection of the primary tumour with vs. without adjuvant therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 and the randomised phase
- Known microsatellite or mismatch repair status
- Confirmation, that the ctDNA result is available
You likely can't join if
- Patients with known microsatellite instability (MSI-H) or mis- match repair deficiency (dMMR)
- Colon or rectal cancer with UICC stage III or IV
- Second cancer, except: simultaneous or metachronous colon or rectal cancer with UICC stage ≤ I, OR curatively treated basal cell carcinoma or squamous cell carcinoma of the skin and in-situ cervical carcinoma OR tumours with a disease free survival of more than five years
- Contra indications for chemotherapy, especially: a) Leukocytes < 3,0 Gpt/l b) Neutrophil granulocytes < 1,5 Gpt/l c) Thrombocytes < 100 Gpt/l d) ALAT or ASAT > 3 x ULN e) Creatinine clearance (calculated according Cockcroft- Gault) < 30 ml/min
- Comorbidities relevantly interfering with the prognosis of the patients, i.e.: a) heart insufficiency NYHA III/IV b) relevant coronary heart disease, c) Diabetes mellitus with late sequelae
- Organ, stem cell or bone marrow transplantation
See the full eligibility criteria
- 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 and the randomised phase
- Known microsatellite or mismatch repair status
- Confirmation, that the ctDNA result is available
- Patients with known microsatellite instability (MSI-H) or mis- match repair deficiency (dMMR)
- Colon or rectal cancer with UICC stage III or IV
- Second cancer, except: simultaneous or metachronous colon or rectal cancer with UICC stage ≤ I, OR curatively treated basal cell carcinoma or squamous cell carcinoma of the skin and in-situ cervical carcinoma OR tumours with a disease free survival of more than five years
- Contra indications for chemotherapy, especially: a) Leukocytes < 3,0 Gpt/l b) Neutrophil granulocytes < 1,5 Gpt/l c) Thrombocytes < 100 Gpt/l d) ALAT or ASAT > 3 x ULN e) Creatinine clearance (calculated according Cockcroft- Gault) < 30 ml/min
- Comorbidities relevantly interfering with the prognosis of the patients, i.e.: a) heart insufficiency NYHA III/IV b) relevant coronary heart disease, c) Diabetes mellitus with late sequelae
- Organ, stem cell or bone marrow transplantation
- Known hypersensitivity to capecitabine. In case of known hypersensitivity to oxaliplatin, the patients can participate, but not receive oxaliplatin.
- Medication with brivudine, sorivudine or analogues in the last four weeks before planned treatment start.
- Known biallelic or homozygous dihydropyrimidine dehydro- genase (DPD)-deficiency
- Acute infections
- Known HIV- infections, known active hepatitis B or C- infection
- Known clinical high risk situation if it is regarded as certain in- dication for an adjuvant chemotherapy
- Participation at another interventional study for medical treat- ment during the last four weeks before randomisation
- Neoadjuvant therapy before resection
- Patients, in whom the randomisation or chemotherapy is un- feasible due to logistic reasons (travel distance, compliance)
- Women of childbearing potential and men with partner with childbearing potential who are not willing to take appropriate precautions to avoid pregnancy with a highly effective method in case they are randomised to “chemotherapy”
- Patients, who have an obvious contra-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbid- ity, 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)
- Patients, in whom the randomisation or chemotherapy is un- feasible due to logistic reasons (travel distance, compliance)
- Age < 18 years
- Pregnant or breast feeding patients
- R1- or R2- status, or unknown R- status (Rx)
- Number of investigated lymph nodes < 10 5) WHO performance status ≥ 2
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.