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

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Jeroen Bosch Ziekenhuis
RECRUITING
's-hertogenbosch
Noordwest Ziekenhuisgroep
RECRUITING
Alkmaar
Ziekenhuisgroep Twente
RECRUITING
Almelo
Flevoziekenhuis
RECRUITING
Almere Stad
Meander Medisch Centrum
RECRUITING
Amersfoort
NKI-AVL
RECRUITING
Amsterdam
Rijnstate
RECRUITING
Arnhem
Amphia Ziekenhuis
RECRUITING
Breda
Reinier de Graaf Gasthuis
RECRUITING
Delft
Deventer Ziekenhuis
RECRUITING
Deventer
Albert Schweizer Ziekenhuis
RECRUITING
Dordrecht
Ziekenhuis Gelderse Vallei
RECRUITING
Ede
Admiraal de Ruyter Ziekenhuis
RECRUITING
Goes
Rivas
RECRUITING
Gorinchem
Spaarne Gasthuis
RECRUITING
Haarlem
Ziekenhuis St. Jansdal
RECRUITING
Harderwijk
Maastricht UMC
RECRUITING
Maastricht
Van Weel-Bethesda Ziekenhuis
RECRUITING
Middelharnis
St. Antonius Ziekenhuis
RECRUITING
Nieuwegein
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Bravis Ziekenhuis
RECRUITING
Roosendaal
Ikazia Ziekenhuis
RECRUITING
Rotterdam
Haaglanden MC
RECRUITING
The Hague
Bernhoven
RECRUITING
Uden
Diakonessenhuis
RECRUITING
Utrecht
UMC Utrecht
RECRUITING
Utrecht
Maxima Medisch Centrum
RECRUITING
Veldhoven
VieCuri Medisch Centrum
RECRUITING
Venlo
St. Jans Gasthuis
RECRUITING
Weert
Contact Information
Primary
Miriam Koopman, Prof. dr.
plcrcmedocc@umcutrecht.nl
+316 46 91 95 66
Time Frame
Start Date: 2020-03-05
Estimated Completion Date: 2035-03
Participants
Target number of participants: 1320
Treatments
Experimental: ctDNA-based treatment group
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.
No_intervention: Standard of care group
The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.
Related Therapeutic Areas
Sponsors
Collaborators: The Netherlands Cancer Institute, Personal Genome Diagnostics
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov