Using blood tests to guide chemotherapy in stage II colon cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves patients with stage II colon cancer who are part of the Dutch ColoRectal Cancer cohort. Participants will be randomly assigned to either a ctDNA-based treatment group or a standard care group. Blood samples will be collected before and after surgery to analyze circulating tumor DNA (ctDNA) levels, which will help determine the need for adjuvant chemotherapy. The goal is to assess whether ctDNA analysis can improve treatment decisions and outcomes for these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Jeroen Bosch Ziekenhuis
  's-Hertogenbosch, Netherlands Recruiting
• Noordwest Ziekenhuisgroep
  Alkmaar, Netherlands Recruiting
• Ziekenhuisgroep Twente
  Almelo, Netherlands Recruiting
• Flevoziekenhuis
  Almere Stad, Netherlands Recruiting
• Meander Medisch Centrum
  Amersfoort, Netherlands Recruiting
• Nki-Avl
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Miriam Koopman, Prof. dr.
• Email: plcrcmedocc@umcutrecht.nl
• Phone: +316 46 91 95 66

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.