Recurrence Clinical Trial
— CrEATEOfficial title:
Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Personal Genome Diagnostics (PGDx), The Netherlands Cancer Institute |
Netherlands,
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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