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

UMC Utrecht

Status: Enrolling

Conditions: Colon Cancer Stage II; Circulating Tumor DNA; Recurrence

Treatments: Other: ctDNA analysis after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06434896

NL71881.041.19

Details and patient eligibility

About

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.

Enrollment: 1,320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,320 participants in 2 patient groups

ctDNA-based treatment group

Experimental group

Description:

Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department.

Treatment:

Other: ctDNA analysis after surgery

Standard of care group

No Intervention group

Description:

The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.