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Recruiting NCT06434896

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

No phase Interventional Circulating Tumor DNA Recurrence Colon Cancer Stage II

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ctDNA analysis after surgery.
Who it may be relevant to
Registry conditions: Circulating Tumor DNA, Recurrence, Colon Cancer Stage II. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood. [Time frame: 8-12 weeks after surgery]
Secondary outcome measures (6)
  • Recurrence Rate [Time frame: 2 and 5 years after surgery]
  • Disease Free Survival rate [Time frame: 2 and 5 years after surgery]
  • Disease-related Overall Survival rate [Time frame: 5 years after surgery]
  • Time to Recurrence [Time frame: From date of randomization until the date of recurrence, assessed up to 5 years.]
  • Quality of Life after treatment [Time frame: 10 years]
  • Cost-effectiveness of the ctDNA-based treatment [Time frame: 5 years after diagnosis]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 29 centers
  • Jeroen Bosch Ziekenhuis — 's-Hertogenbosch
  • Noordwest Ziekenhuisgroep — Alkmaar
  • Ziekenhuisgroep Twente — Almelo
  • Flevoziekenhuis — Almere Stad
  • Meander Medisch Centrum — Amersfoort
  • NKI-AVL — Amsterdam
  • Rijnstate — Arnhem
  • Amphia Ziekenhuis — Breda
  • … and 21 more centers

Identifiers

NCT: NCT06434896 · NL71881.041.19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗