RecruitingPhase 3NCT04089631

Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation

Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation (CIRCULATE) AIO-KRK-0217


Sponsor

Technische Universität Dresden

Enrollment

4,812 participants

Start Date

Jun 26, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether a blood test that detects tumor DNA (ctDNA) can guide decisions about whether people with Stage II colon cancer need chemotherapy after surgery, potentially sparing some patients from unnecessary treatment. **You may be eligible if...** - You have had surgery for Stage II colon cancer (or Stage II rectal cancer in the upper rectum) - Your microsatellite or mismatch repair status is known - Your ctDNA result is available - You have signed informed consent for both the screening and randomized phases **You may NOT be eligible if...** - Your cancer is microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) - You have a known reason to definitely need chemotherapy - You have a condition that makes chemotherapy unsafe - Your cancer was not completely removed (R1 or R2 status) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

6 months capecitabine, in combination with oxaliplatin 3 to 6 months capecitabine


Locations(1)

Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik

Dresden, Saxony, Germany

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NCT04089631


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