Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): Study protocol for a trial within a cohort study

Autor: Schraa, S. J., Van Rooijen, K. L., Van Der Kruijssen, D. E.W., Rubio Alarcón, C., Phallen, J., Sausen, M., Simmons, J., Coupé, V. M.H., Van Grevenstein, W. M.U., Elias, S., Verkooijen, H. M., Laclé, M. M., Bosch, L. J.W., Van Den Broek, D., Meijer, G. A., Velculescu, V. E., Fijneman, R. J.A., Vink, G. R., Koopman, M., Dunker, Mich S., Lutke Holzik, Martijn F., Hoekstra, Ronald, Sommeijer, Dirkje W., Van Der Bilt, Jarmila D.W., Consten, Esther C.J., Cirkel, Geert A., Burghgraef, Thijs A., Van Der Schans, Emma M., Nieboer, Peter, Rietbroek, Ron C., Dekker, Jan Willem T., Verschoor, Arjan J., Talsma, Koen A.K., Brosens, Rebecca P.M., Helgason, Helgi H., Marinelli, Andreas W.K.S., De Hingh, Ignace H.J.T., Oldenhuis, Corina N., Jansen, Jan, Van Halteren, Henk K., Stockmann, Hein B.A.C., Beeker, Aart, Bosscha, Koop, Pruijt, Hans F.M., Spierings, Leontine E.A.M.M., Valkenburg-Van Iersel, Liselot B.J., Vles, Wouter J., De Jongh, Felix E., Van Cruijsen, Hester, Heikens, Joost T., Zimmerman, David D.E., Van Alphen, Robert J., Schiphorst, Anandi H.W., Van Leeuwen-Snoeks, Lobke L., Vogelaar, Jeroen F.J., Peters, Natascha A.J.B.
Přispěvatelé: Epidemiology and Data Science, APH - Methodology, CCA - Cancer Treatment and quality of life, Pathology, Internal medicine, Orthopedic Surgery and Sports Medicine, VU University medical center, Surgery, ​Robotics and image-guided minimally-invasive surgery (ROBOTICS), RS: NUTRIM - R3 - Respiratory & Age-related Health, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA Medische Oncologie (9), Medical Biology, Nephrology, Oncology
Jazyk: angličtina
Rok vydání: 2020
Předmět:
0301 basic medicine
Oncology
Male
Cancer Research
Neoplasm
Residual
Colorectal cancer
Cost-Benefit Analysis
COLORECTAL-CANCER
Circulating Tumor DNA
Study Protocol
0302 clinical medicine
RESIDUAL DISEASE
Antineoplastic Combined Chemotherapy Protocols
Clinical endpoint
Prospective Studies
Colectomy
Netherlands
Randomized Controlled Trials as Topic
RISK
education.field_of_study
RANDOMIZED CONTROLLED-TRIAL
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Colon cancer
Oxaliplatin
Chemotherapy
Adjuvant
CELL-FREE DNA
030220 oncology & carcinogenesis
Colonic Neoplasms
Practice Guidelines as Topic
SURVIVAL
Female
medicine.drug
Cohort study
Adult
medicine.medical_specialty
Population
TwiCs
lcsh:RC254-282
Disease-Free Survival
LEUCOVORIN
Capecitabine
03 medical and health sciences
Internal medicine
Genetics
medicine
Biomarkers
Tumor
Humans
RECURRENCE
education
Neoplasm Staging
Intention-to-treat analysis
business.industry
Liquid Biopsy
ctDNA
Patient Acceptance of Health Care
medicine.disease
Minimal residual disease
FLUOROURACIL
Adjuvant chemotherapy
030104 developmental biology
Quality of Life
Neoplasm Recurrence
Local
business
Follow-Up Studies
Zdroj: BMC Cancer, 20(1):790. BioMed Central
BMC Cancer, 20(1):790. BMC
BMC Cancer
Schraa, S J, Van Rooijen, K L, Van Der Kruijssen, D E W, Rubio Alarcón, C, Phallen, J, Sausen, M, Simmons, J, Coupé, V M H, Van Grevenstein, W M U, Elias, S, Verkooijen, H M, Laclé, M M, Bosch, L J W, Van Den Broek, D, Meijer, G A, Velculescu, V E, Fijneman, R J A, Vink, G R, Koopman, M, Dunker, M S, Lutke Holzik, M F, Hoekstra, R, Sommeijer, D W, Van Der Bilt, J D W, Consten, E C J, Cirkel, G A, Burghgraef, T A, Van Der Schans, E M, Nieboer, P, Rietbroek, R C, Dekker, J W T, Verschoor, A J, Talsma, K A K, Brosens, R P M, Helgason, H H, Marinelli, A W K S, De Hingh, I H J T, Oldenhuis, C N, Jansen, J, Van Halteren, H K, Stockmann, H B A C, Beeker, A, Bosscha, K, Pruijt, H F M, Spierings, L E A M M, Valkenburg-Van Iersel, L B J, Vles, W J, De Jongh, F E, Van Cruijsen, H, Heikens, J T, Zimmerman, D D E, Van Alphen, R J, Schiphorst, A H W, Van Leeuwen-Snoeks, L L, Vogelaar, J F J & Peters, N A J B 2020, ' Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE) : Study protocol for a trial within a cohort study ', BMC Cancer, vol. 20, no. 1, 790 . https://doi.org/10.1186/s12885-020-07252-y
BMC Cancer, 20(1):790. BioMed Central Ltd
BMC cancer, 20(1):790. BioMed Central
BMC Cancer, Vol 20, Iss 1, Pp 1-10 (2020)
ISSN: 1471-2407
DOI: 10.1186/s12885-020-07252-y
Popis: Background Accurate detection of patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC) remains an urgent unmet clinical need to improve selection of patients who might benefit form adjuvant chemotherapy (ACT). Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease. The MEDOCC-CrEATE trial investigates how many stage II CC patients with detectable ctDNA after surgery will accept ACT and whether ACT reduces the risk of recurrence in these patients. Methods/design MEDOCC-CrEATE follows the ‘trial within cohorts’ (TwiCs) design. Patients with colorectal cancer (CRC) are included in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) and give informed consent for collection of clinical data, tissue and blood samples, and consent for future randomization. MEDOCC-CrEATE is a subcohort within PLCRC consisting of 1320 stage II CC patients without indication for ACT according to current guidelines, who are randomized 1:1 into an experimental and a control arm. In the experimental arm, post-surgery blood samples and tissue are analyzed for tissue-informed detection of plasma ctDNA, using the PGDx elio™ platform. Patients with detectable ctDNA will be offered ACT consisting of 8 cycles of capecitabine plus oxaliplatin while patients without detectable ctDNA and patients in the control group will standard follow-up according to guideline. The primary endpoint is the proportion of patients receiving ACT when ctDNA is detectable after resection. The main secondary outcome is 2-year recurrence rate (RR), but also includes 5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness. Data will be analyzed by intention to treat. Discussion The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group. Trial registration Netherlands Trial Register: NL6281/NTR6455. Registered 18 May 2017, https://www.trialregister.nl/trial/6281
Databáze: OpenAIRE
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