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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06434896
Other study ID # NL71881.041.19
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 5, 2020
Est. completion date March 2035

Study information

Verified date May 2024
Source UMC Utrecht
Contact Miriam Koopman, Prof. dr.
Phone +316 46 91 95 66
Email plcrcmedocc@umcutrecht.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1320
Est. completion date March 2035
Est. primary completion date March 2035
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design


Intervention

Other:
ctDNA analysis after surgery
ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.

Locations

Country Name City State
Netherlands Jeroen Bosch Ziekenhuis 's Hertogenbosch
Netherlands Noordwest Ziekenhuisgroep Alkmaar
Netherlands Ziekenhuisgroep Twente Almelo
Netherlands Flevoziekenhuis Almere
Netherlands Meander Medisch Centrum Amersfoort
Netherlands Rijnstate Arnhem
Netherlands Amphia Ziekenhuis Breda
Netherlands Reinier de Graaf Gasthuis Delft
Netherlands Haaglanden MC Den Haag
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 Bernhoven Uden
Netherlands Diakonessenhuis Utrecht
Netherlands UMC Utrecht Utrecht
Netherlands Maxima Medisch Centrum Veldhoven
Netherlands VieCuri Medisch Centrum Venlo
Netherlands St. Jans Gasthuis Weert

Sponsors (3)

Lead Sponsor Collaborator
UMC Utrecht Personal Genome Diagnostics (PGDx), The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood. 8-12 weeks after surgery
Secondary Recurrence Rate Proportion of patients that will experience disease recurrence 2 and 5 years after surgery
Secondary Disease Free Survival rate Proportion of patients that are alive and free of disease 2 and 5 years after surgery
Secondary Disease-related Overall Survival rate Proportion of patients that are alive 5 years after surgery
Secondary Time to Recurrence From date of randomization until the date of recurrence, assessed up to 5 years.
Secondary Quality of Life after treatment Quality of Life will be measured using questionnaires that are provided to patients who have given informed consent for the collection of questionnaires within PLCRC. 10 years
Secondary Cost-effectiveness of the ctDNA-based treatment 5 years after diagnosis
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