Clinical trial NCT06434896: Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
Official title: Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Circulating Tumor DNA
Recurrence
Colon Cancer Stage II
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Personal Genome Diagnostics
name: The Netherlands Cancer Institute
First posted: 2024-05-30
Enrollment: 1320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: DIAGNOSTIC

Brief 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 criteria: 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

Primary outcomes:
measure: Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
timeFrame: 8-12 weeks after surgery
Secondary outcomes:
measure: Recurrence Rate
timeFrame: 2 and 5 years after surgery
measure: Disease Free Survival rate
timeFrame: 2 and 5 years after surgery
measure: Disease-related Overall Survival rate
timeFrame: 5 years after surgery
measure: Time to Recurrence
timeFrame: From date of randomization until the date of recurrence, assessed up to 5 years.
measure: Quality of Life after treatment
timeFrame: 10 years
measure: Cost-effectiveness of the ctDNA-based treatment
timeFrame: 5 years after diagnosis
Other outcomes:
Locations:
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: NKI-AVL
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Den Haag
country: Netherlands
facility: Haaglanden MC
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweizer Ziekenhuis
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
city: Gorinchem
country: Netherlands
facility: Rivas
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Harderwijk
country: Netherlands
facility: Ziekenhuis St. Jansdal
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Middelharnis
country: Netherlands
facility: Van Weel-Bethesda Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Bravis Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Uden
country: Netherlands
facility: Bernhoven
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum
city: Weert
country: Netherlands
facility: St. Jans Gasthuis
Study officials:
References: