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

Recurrence Clinical Trial

— CrEATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06434896
• Other study ID #: NL71881.041.19
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Circulating Tumor DNA
• Colon Cancer Stage II
• Colonic Neoplasms
• Recurrence

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