Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial

Summary

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

Eligibility

Inclusion Criteria:

* Age ≥ 18 years
* Informed consent for PLCRC with specific consent for:

  * additional blood withdrawals
  * collection and use of tissue for scientific research
  * invitation for future (experimental) research within the cohort, including TwiCs studies
* Inclusion in observational PLCRC -MEDOCC substudy
* Histological confirmed stage II colon cancer
* Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician

Exclusion Criteria:

* Indication for adjuvant chemotherapy according to treating physician
* Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
* Incomplete primary tumor resection (R1 or R2 resection)
* Contra-indication for fluoropyrimidines or oxaliplatin
* Pregnancy

Conditions4

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