NCT04089631 Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation
| NCT ID | NCT04089631 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Technische Universität Dresden |
| Condition | Colon Cancer Stage II |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,812 participants |
| Start Date | 2020-06-26 |
| Primary Completion | 2023-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 4,812 participants in total. It began in 2020-06-26 with a primary completion date of 2023-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion criteria for screening phase: 1. 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. 2. Signed informed consent for the screening Phase Inclusion criteria for the randomised phase: 1. 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. 2. Known microsatellite or mismatch repair status 3. Confirmation, that the ctDNA result is available 4. Signed second informed consent (for the randomised phase) Exclusion criteria for Screening: 1. Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) 2. Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy 3. 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. 4. R1- or R2-status (patients with \[still\] unknown R-status can be screened) 5. Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance) 6. Age \< 18 years 7. Pregnant or breast feeding patients Exclusion criteria for randomised phase: 1. Patients with microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) 2. Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy 3. R1- or R2- status, or unknown R- status (Rx) 4. Number of investigated lymph nodes \< 10 5. WHO performance status ≥ 2 6. Colon or rectal cancer with UICC stage III or IV 7. Second cancer, except 1. simultaneous or metachronous colon or rectal cancer with UICC stage ≤ I, 2. curatively treated basal cell carcinoma or squamous cell carcinoma of the skin and in-situ cervical carcinoma 3. tumours with a disease free survival of more than five years 8. Contra indications for chemotherapy, especially: 1. Leukocytes \< 3,0 Gpt/l 2. Neutrophil granulocytes \< 1,5 Gpt/l 3. Thrombocytes \< 100 Gpt/l 4. alanine aminotransferase (ALAT) or (aspartate aminotransferase) ASAT \> 3x ULN 5. Creatinine clearance (calculated according Cockcroft-Gault) \< 30 ml/min 9. Comorbidities relevantly interfering with the prognosis of the patients, i.e.: 1. heart insufficiency NYHA III/IV 2. relevant coronary heart disease, 3. Diabetes mellitus with late sequelae 10. Organ, stem cell or bone marrow transplantation 11. Known hypersensitivity to capecitabine In case of known hypersensitivity to oxaliplatin, the patients can participate, but not receive oxaliplatin 12. Medication with brivudine, sorivudine or analogues in the last four weeks before planned treatment start 13. Known dihydropyrimidine dehydrogenase (DPD)-deficiency 14. Acute infections 15. Known HIV- infections, known active hepatitis B or C-infection 16. Participation at another interventional study for medical treatment during the last four weeks before randomisation 17. Neoadjuvant therapy before resection 18. Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance) 19. Age \< 18 years 20. Pregnant or breast feeding patients 21. 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"
Contact & Investigator
Gunnar Folprecht, Prof.
PRINCIPAL INVESTIGATOR
University hospital "Carl Gustav Carus" Dresden
Frequently Asked Questions
Who can join the NCT04089631 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colon Cancer Stage II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04089631 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 4,812 participants.
Is NCT04089631 currently recruiting?
Yes, NCT04089631 is actively recruiting participants. Contact the research team at Gunnar.Folprecht@uniklinikum-dresden.de for enrollment information.
Where is the NCT04089631 trial being conducted?
This trial is being conducted at Dresden, Germany.
Who is sponsoring the NCT04089631 clinical trial?
NCT04089631 is sponsored by Technische Universität Dresden. The principal investigator is Gunnar Folprecht, Prof. at University hospital "Carl Gustav Carus" Dresden. The trial plans to enroll 4,812 participants.
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