Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
Recruiting · NCT06434896 · Interventional (participants receive a specific treatment) · Lead sponsor: UMC Utrecht
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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 is running
29 locations listed.
- Jeroen Bosch Ziekenhuis - 's-Hertogenbosch, Netherlands
- Noordwest Ziekenhuisgroep - Alkmaar, Netherlands
- Ziekenhuisgroep Twente - Almelo, Netherlands
- Flevoziekenhuis - Almere Stad, Netherlands
- Meander Medisch Centrum - Amersfoort, Netherlands
- NKI-AVL - Amsterdam, Netherlands
- Rijnstate - Arnhem, Netherlands
- Amphia Ziekenhuis - Breda, Netherlands
- Reinier de Graaf Gasthuis - Delft, Netherlands
- Deventer Ziekenhuis - Deventer, Netherlands
- Albert Schweizer Ziekenhuis - Dordrecht, Netherlands
- Ziekenhuis Gelderse Vallei - Ede, Netherlands
- Admiraal de Ruyter Ziekenhuis - Goes, Netherlands
- Rivas - Gorinchem, Netherlands
- Spaarne Gasthuis - Haarlem, Netherlands
- Ziekenhuis St. Jansdal - Harderwijk, Netherlands
- Maastricht UMC - Maastricht, Netherlands
- Van Weel-Bethesda Ziekenhuis - Middelharnis, Netherlands
- St. Antonius Ziekenhuis - Nieuwegein, Netherlands
- Canisius Wilhelmina Ziekenhuis - Nijmegen, Netherlands
- Bravis Ziekenhuis - Roosendaal, Netherlands
- Ikazia Ziekenhuis - Rotterdam, Netherlands
- Haaglanden MC - The Hague, Netherlands
- Bernhoven - Uden, Netherlands
- Diakonessenhuis - Utrecht, Netherlands
- UMC Utrecht - Utrecht, Netherlands
- Maxima Medisch Centrum - Veldhoven, Netherlands
- VieCuri Medisch Centrum - Venlo, Netherlands
- St. Jans Gasthuis - Weert, Netherlands