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16 results on '"Valkenburg-van Iersel, Liselot B.J."'

1. Trastuzumab plus pertuzumab for HER2-amplified advanced colorectal cancer: Results from the drug rediscovery protocol (DRUP)

Author

Spiekman, Ilse A.C., Zeverijn, Laurien J., Geurts, Birgit S., Verkerk, Karlijn, Haj Mohammad, Soemeya F., van der Noort, Vincent, Roepman, Paul, de Leng, Wendy W.J., Jansen, Anne M.L., Gootjes, Elske C., de Groot, Derk-Jan A., Kerver, Emile D., van Voorthuizen, Theo, Roodhart, Jeanine M.L., Valkenburg-van Iersel, Liselot B.J., Gelderblom, Hans, Voest, Emile E., and Verheul, Henk M.W.

Published
2024
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2. Population-based impact of COVID-19 on incidence, treatment, and survival of patients with pancreatic cancer

Author

Siesling, S., van Hoeve, J.C., Merkx, M.A.W., de Wit, N.J., Helsper, C.W., Dingemans, I., Nagtegaal, I.D., van der Schaaf, M., van Gils, C.H., van Weert, H.C.P.M., Verheij, M., Graus, Merlijn U.J.E., de Hingh, Ignace H.J.T., Besselink, Marc G., Bruno, Marco J., Wilmink, Johanna W., de Meijer, Vincent E., van Velthuysen, Marie-Louise F., Valkenburg-van Iersel, Liselot B.J., van der Geest, Lydia G.M., and de Vos-Geelen, Judith

Published
2023
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3. First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases (CAIRO5): an open-label, multicentre, randomised, controlled, phase 3 study from the Dutch Colorectal Cancer Group

Author

Van Gulik, Thomas, Huiskens, Joost, Van Tinteren, Harm, Dejong, Cornelis H.C., Grünhagen, Dirk J., Patijn, Gijs A., Ruers, Theo J.M., Chapelle, Thiery, Hermans, John J., Leclercq, Wouter K.G., Valkenburg-van Iersel, Liselot B.J., Grootscholten, Cecile, Van Dodewaard-de Jong, Joyce M., Vincent, Jeroen, Houtsma, Danny, Los, Maartje, Den Boer, Marien, Trajkovic-Vidakovic, Marija, Van Voorthuizen, Theo, Koopman, Miriam, Vestjens, Johanneke H.M.J.V., Torrenga, Hans, Mekenkamp, Leonie J., Veldhuis, Gerrit Jan, Polee, Marco B., Dohmen, Serge E., Schut, Heidi, Vulink, Annelie J.E., Van Halteren, Henk K., Oulad Hadj, Jamal, Schiphorst, Pieter-Paul J.B.M., Hoekstra, Ronald, Bond, Marinde J G, Bolhuis, Karen, Loosveld, Olaf J L, de Groot, Jan Willem B, Droogendijk, Helga, Helgason, Helgi H, Hendriks, Mathijs P, Klaase, Joost M, Kazemier, Geert, Liem, Mike S L, Rijken, Arjen M, Verhoef, Cornelis, de Wilt, Johannes H W, de Jong, Koert P, Gerhards, Michael F, van Amerongen, Martinus J, Engelbrecht, Marc R W, van Lienden, Krijn P, Molenaar, I Quintus, de Valk, Bart, Haberkorn, Brigitte C M, Kerver, Emile D, Erdkamp, Frans, van Alphen, Robbert J, Mathijssen-van Stein, Daniëlle, Komurcu, Aysun, Lopez-Yurda, Marta, Swijnenburg, Rutger-Jan, and Punt, Cornelis J A

Published
2023
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4. Treatment and overall survival of four types of non-metastatic periampullary cancer: nationwide population-based cohort study

Author

de Jong, Evelien J.M., van der Geest, Lydia G., Besselink, Marc G., Bouwense, Stefan A.W., Buijsen, Jeroen, Dejong, C.H.C., Koerkamp, Bas G., Heij, Lara R., de Hingh, Ignace H.J.T., Hoge, Chantal, Kazemier, Geert, van Laarhoven, Hanneke W.M., de Meijer, Vincent E., Stommel, Martijn W.J., Tjan-Heijnen, Vivianne C.G., Valkenburg-van Iersel, Liselot B.J., Wilmink, Johanna W., Geurts, Sandra M.E., and de Vos-Geelen, Judith

Published
2022
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5. Quality of Life and Survival of Metastatic Colorectal Cancer Patients Treated With Trifluridine-Tipiracil (QUALITAS)

Author

Beerepoot, Laurens V., Creemers, Geert-Jan, van Cruijsen, Hester, de Groot, Jan Willem B., van Halteren, Henk K., Helgason, Helgi H., Hendriks, Mathijs P., Hoekstra, Ronald, van Huis-Tanja, Lieke H., Kapiteijn, Ellen, Los, Maartje, van Meerten, Esther, Peters, Natascha A.J.B., Pruijt, Johannes F.M., van Ufford-Mannesse, Patricia Quarles, Sie, Mark P.S., Sommeijer, Dirkje W., Spierings, Leontine E.A.M.M., Terheggen, Frederiek, Tjin-A-Ton, Manuel L.R., Valkenburg-van Iersel, Liselot B.J., van Voorthuizen, Theo, de Vos-Geelen, Judith, Vulink, Annelie J.E., J van de Wouw, Agnès, Hamers, Patricia A.H., Vink, Geraldine R., Elferink, Marloes A.G., Stellato, Rebecca K., Dijksterhuis, Willemieke P.M., Punt, Cornelis J.A., Koopman, Miriam, and May, Anne M.

Published
2022
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6. A population-based study on incidence, treatment, and survival in ampullary cancer in the Netherlands

Author

de Jong, Evelien J.M., Geurts, Sandra M.E., van der Geest, Lydia G., Besselink, Marc G., Bouwense, Stefan A.W., Buijsen, Jeroen, Dejong, Cornelis H.C., Heij, Lara R., Koerkamp, Bas Groot, de Hingh, Ignace H.J.T., Hoge, Chantal, Kazemier, Geert, van Laarhoven, Hanneke W.M., de Meijer, Vincent E., Mohammad, Nadia Haj, Strijker, Marin, Timmermans, Karin C.A.A., Valkenburg-van Iersel, Liselot B.J., Wilmink, Johanna W., Tjan-Heijnen, Vivianne C.G., and de Vos-Geelen, Judith

Published
2021
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7. First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases (CAIRO5): an open-label, multicentre, randomised, controlled, phase 3 study from the Dutch Colorectal Cancer Group

Author

Bond, Marinde J G, primary, Bolhuis, Karen, additional, Loosveld, Olaf J L, additional, de Groot, Jan Willem B, additional, Droogendijk, Helga, additional, Helgason, Helgi H, additional, Hendriks, Mathijs P, additional, Klaase, Joost M, additional, Kazemier, Geert, additional, Liem, Mike S L, additional, Rijken, Arjen M, additional, Verhoef, Cornelis, additional, de Wilt, Johannes H W, additional, de Jong, Koert P, additional, Gerhards, Michael F, additional, van Amerongen, Martinus J, additional, Engelbrecht, Marc R W, additional, van Lienden, Krijn P, additional, Molenaar, I Quintus, additional, de Valk, Bart, additional, Haberkorn, Brigitte C M, additional, Kerver, Emile D, additional, Erdkamp, Frans, additional, van Alphen, Robbert J, additional, Mathijssen-van Stein, Daniëlle, additional, Komurcu, Aysun, additional, Lopez-Yurda, Marta, additional, Swijnenburg, Rutger-Jan, additional, Punt, Cornelis J A, additional, Van Gulik, Thomas, additional, Huiskens, Joost, additional, Van Tinteren, Harm, additional, Dejong, Cornelis H.C., additional, Grünhagen, Dirk J., additional, Patijn, Gijs A., additional, Ruers, Theo J.M., additional, Chapelle, Thiery, additional, Hermans, John J., additional, Leclercq, Wouter K.G., additional, Valkenburg-van Iersel, Liselot B.J., additional, Grootscholten, Cecile, additional, Van Dodewaard-de Jong, Joyce M., additional, Vincent, Jeroen, additional, Houtsma, Danny, additional, Los, Maartje, additional, Den Boer, Marien, additional, Trajkovic-Vidakovic, Marija, additional, Van Voorthuizen, Theo, additional, Koopman, Miriam, additional, Vestjens, Johanneke H.M.J.V., additional, Torrenga, Hans, additional, Mekenkamp, Leonie J., additional, Veldhuis, Gerrit Jan, additional, Polee, Marco B., additional, Dohmen, Serge E., additional, Schut, Heidi, additional, Vulink, Annelie J.E., additional, Van Halteren, Henk K., additional, Oulad Hadj, Jamal, additional, Schiphorst, Pieter-Paul J.B.M., additional, and Hoekstra, Ronald, additional

Published
2023
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8. Population-based impact of COVID-19 on incidence, treatment, and survival of patients with pancreatic cancer

Author

Graus, Merlijn U.J.E., primary, de Hingh, Ignace H.J.T., additional, Besselink, Marc G., additional, Bruno, Marco J., additional, Wilmink, Johanna W., additional, de Meijer, Vincent E., additional, van Velthuysen, Marie-Louise F., additional, Valkenburg-van Iersel, Liselot B.J., additional, van der Geest, Lydia G.M., additional, de Vos-Geelen, Judith, additional, Siesling, S., additional, van Hoeve, J.C., additional, Merkx, M.A.W., additional, de Wit, N.J., additional, Helsper, C.W., additional, Dingemans, I., additional, Nagtegaal, I.D., additional, van der Schaaf, M., additional, van Gils, C.H., additional, van Weert, H.C.P.M., additional, and Verheij, M., additional

Published
2023
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9. Population-based impact of COVID-19 on incidence, treatment, and survival of patients with pancreatic cancer

Author

Graus, Merlijn U.J.E., de Hingh, Ignace H.J.T., Besselink, Marc G., Bruno, Marco J., Wilmink, Johanna W., de Meijer, Vincent E., van Velthuysen, Marie Louise F., Valkenburg-van Iersel, Liselot B.J., van der Geest, Lydia G.M., de Vos-Geelen, Judith, Siesling, S., van Hoeve, J. C., Merkx, M. A.W., de Wit, N. J., Helsper, C. W., Dingemans, I., Nagtegaal, I. D., van der Schaaf, M., van Gils, C. H., van Weert, H. C.P.M., Verheij, M., Graus, Merlijn U.J.E., de Hingh, Ignace H.J.T., Besselink, Marc G., Bruno, Marco J., Wilmink, Johanna W., de Meijer, Vincent E., van Velthuysen, Marie Louise F., Valkenburg-van Iersel, Liselot B.J., van der Geest, Lydia G.M., de Vos-Geelen, Judith, Siesling, S., van Hoeve, J. C., Merkx, M. A.W., de Wit, N. J., Helsper, C. W., Dingemans, I., Nagtegaal, I. D., van der Schaaf, M., van Gils, C. H., van Weert, H. C.P.M., and Verheij, M.

Abstract

Background: The COVID-19 pandemic has put substantial strain on the healthcare system of which the effects are only partly elucidated. This study aimed to investigate the impact on pancreatic cancer care. Methods: All patients diagnosed with pancreatic cancer between 2017 and 2020 were selected from the Netherlands Cancer Registry. Patients diagnosed and/or treated in 2020 were compared to 2017–2019. Monthly incidence was calculated. Patient, tumor and treatment characteristics were analyzed and compared using Chi-squared tests. Survival data was analyzed using Kaplan–Meier and Log-rank tests. Results: In total, 11019 patients were assessed. The incidence in quarter (Q)2 of 2020 was comparable with that in Q2 of 2017–2019 (p = 0.804). However, the incidence increased in Q4 of 2020 (p = 0.031), mainly due to a higher incidence of metastatic disease (p = 0.010). Baseline characteristics, surgical resection (15% vs 16%; p = 0.466) and palliative systemic therapy rates (23% vs 24%; p = 0.183) were comparable. In 2020, more surgically treated patients received (neo)adjuvant treatment compared to 2017–2019 (73% vs 67%; p = 0.041). Median overall survival was comparable (3.8 vs 3.8 months; p = 0.065). Conclusion: This nationwide study found a minor impact of the COVID-19 pandemic on pancreatic cancer care and outcome. The Dutch health care system was apparently able to maintain essential care for patients with pancreatic cancer.

Published
2023

10. Quality of Life and Survival of Metastatic Colorectal Cancer Patients Treated With Trifluridine-Tipiracil (QUALITAS)

Author

Hamers, Patricia A.H., primary, Vink, Geraldine R., additional, Elferink, Marloes A.G., additional, Stellato, Rebecca K., additional, Dijksterhuis, Willemieke P.M., additional, Punt, Cornelis J.A., additional, Koopman, Miriam, additional, May, Anne M., additional, Beerepoot, Laurens V., additional, Creemers, Geert-Jan, additional, van Cruijsen, Hester, additional, de Groot, Jan Willem B., additional, van Halteren, Henk K., additional, Helgason, Helgi H., additional, Hendriks, Mathijs P., additional, Hoekstra, Ronald, additional, van Huis-Tanja, Lieke H., additional, Kapiteijn, Ellen, additional, Los, Maartje, additional, van Meerten, Esther, additional, Peters, Natascha A.J.B., additional, Pruijt, Johannes F.M., additional, van Ufford-Mannesse, Patricia Quarles, additional, Sie, Mark P.S., additional, Sommeijer, Dirkje W., additional, Spierings, Leontine E.A.M.M., additional, Terheggen, Frederiek, additional, Tjin-A-Ton, Manuel L.R., additional, Valkenburg-van Iersel, Liselot B.J., additional, van Voorthuizen, Theo, additional, de Vos-Geelen, Judith, additional, Vulink, Annelie J.E., additional, and J van de Wouw, Agnès, additional

Published
2022
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11. Real-world evidence of adjuvant gemcitabine plus capecitabine vs gemcitabine monotherapy for pancreatic ductal adenocarcinoma

Author

de Jong, Evelien J.M., Janssen, Quisette P., Simons, Tessa F.A., Besselink, Marc G., Bonsing, Bert A., Bouwense, Stefan A.W., Geurts, Sandra M.E., Homs, Marjolein Y.V., de Meijer, Vincent E., Tjan-Heijnen, Vivianne C.G., van Laarhoven, Hanneke W.M., Valkenburg-van Iersel, Liselot B.J., Wilmink, Johanna W., van der Geest, Lydia G., Koerkamp, Bas Groot, de Vos-Geelen, Judith, de Jong, Evelien J.M., Janssen, Quisette P., Simons, Tessa F.A., Besselink, Marc G., Bonsing, Bert A., Bouwense, Stefan A.W., Geurts, Sandra M.E., Homs, Marjolein Y.V., de Meijer, Vincent E., Tjan-Heijnen, Vivianne C.G., van Laarhoven, Hanneke W.M., Valkenburg-van Iersel, Liselot B.J., Wilmink, Johanna W., van der Geest, Lydia G., Koerkamp, Bas Groot, and de Vos-Geelen, Judith

Abstract

The added value of capecitabine to adjuvant gemcitabine monotherapy (GEM) in pancreatic ductal adenocarcinoma (PDAC) was shown by the ESPAC-4 trial. Real-world data on the effectiveness of gemcitabine plus capecitabine (GEMCAP), in patients ineligible for mFOLFIRINOX, are lacking. Our study assessed whether adjuvant GEMCAP is superior to GEM in a nationwide cohort. Patients treated with adjuvant GEMCAP or GEM after resection of PDAC without preoperative treatment were identified from The Netherlands Cancer Registry (2015-2019). The primary outcome was overall survival (OS), measured from start of chemotherapy. The treatment effect of GEMCAP vs GEM was adjusted for sex, age, performance status, tumor size, lymph node involvement, resection margin and tumor differentiation in a multivariable Cox regression analysis. Secondary outcome was the percentage of patients who completed the planned six adjuvant treatment cycles. Overall, 778 patients were included, of whom 21.1% received GEMCAP and 78.9% received GEM. The median OS was 31.4 months (95% CI 26.8-40.7) for GEMCAP and 22.1 months (95% CI 20.6-25.0) for GEM (HR: 0.71, 95% CI 0.56-0.90; logrank P =.004). After adjustment for prognostic factors, survival remained superior for patients treated with GEMCAP (HR: 0.73, 95% CI 0.57-0.92, logrank P =.009). Survival with GEMCAP was superior to GEM in most subgroups of prognostic factors. Adjuvant chemotherapy was completed in 69.5% of the patients treated with GEMCAP and 62.7% with GEM (P =.11). In this nationwide cohort of patients with PDAC, adjuvant GEMCAP was associated with superior survival as compared to GEM monotherapy and number of cycles was similar.

Published
2022

12. Treatment and overall survival of four types of non-metastatic periampullary cancer:nationwide population-based cohort study

Author

de Jong, Evelien J.M., van der Geest, Lydia G., Besselink, Marc G., Bouwense, Stefan A.W., Buijsen, Jeroen, Dejong, C. H.C., Koerkamp, Bas G., Heij, Lara R., de Hingh, Ignace H.J.T., Hoge, Chantal, Kazemier, Geert, van Laarhoven, Hanneke W.M., de Meijer, Vincent E., Stommel, Martijn W.J., Tjan-Heijnen, Vivianne C.G., Valkenburg-van Iersel, Liselot B.J., Wilmink, Johanna W., Geurts, Sandra M.E., de Vos-Geelen, Judith, de Jong, Evelien J.M., van der Geest, Lydia G., Besselink, Marc G., Bouwense, Stefan A.W., Buijsen, Jeroen, Dejong, C. H.C., Koerkamp, Bas G., Heij, Lara R., de Hingh, Ignace H.J.T., Hoge, Chantal, Kazemier, Geert, van Laarhoven, Hanneke W.M., de Meijer, Vincent E., Stommel, Martijn W.J., Tjan-Heijnen, Vivianne C.G., Valkenburg-van Iersel, Liselot B.J., Wilmink, Johanna W., Geurts, Sandra M.E., and de Vos-Geelen, Judith

Abstract

Background: Periampullary adenocarcinoma consists of pancreatic adenocarcinoma (PDAC), distal cholangiocarcinoma (DC), ampullary cancer (AC), and duodenal adenocarcinoma (DA). The aim of this study was to assess treatment modalities and overall survival by tumor origin. Methods: Patients diagnosed with non-metastatic periampullary cancer in 2012–2018 were identified from the Netherlands Cancer Registry. OS was studied with Kaplan–Meier analysis and multivariable Cox regression analyses, stratified by origin. Results: Among the 8758 patients included, 68% had PDAC, 13% DC, 12% AC, and 7% DA. Resection was performed in 35% of PDAC, 56% of DC, 70% of AC, and 59% of DA. Neoadjuvant and/or adjuvant therapy was administered in 22% of PDAC, 7% of DC, 7% of AC, and 12% of DA. Three-year OS was highest for AC (37%) and DA (34%), followed by DC (21%) and PDAC (11%). Adjuvant therapy was associated with improved OS among PDAC (HR = 0.62; 95% CI 0.55–0.69) and DC (HR = 0.69; 95% CI 0.48–0.98), but not AC (HR = 0.87; 95% CI 0.62–1.22) and DA (HR = 0.85; 95% CI 0.48–1.50). Conclusion: This retrospective study identified considerable differences in treatment modalities and OS between the four periampullary cancer origins in daily clinical practice. An improved OS after adjuvant chemotherapy could not be demonstrated in patients with AC and DA.

Published
2022

14. Trajectories of health-related quality of life and psychological distress in patients with colorectal cancer: A population-based study

Author

Qaderi, Seyed M., primary, van der Heijden, Joost A.G., additional, Verhoeven, Rob H.A., additional, de Wilt, Johannes H.W., additional, Custers, Jose A.E., additional, Beets, Geerard L., additional, Belt, Eric J.Th., additional, Berbée, Maaike, additional, Beverdam, Frederique H., additional, Blankenburgh, Ruud, additional, Coene, Peter Paul L.O., additional, de Groot, Jan Willem B., additional, de Hingh, Ignace H.J.T., additional, de Vos, Aad I., additional, Dekker, Jan Willem T., additional, Erdkamp, Frans L.G., additional, Haringhuizen, Annebeth W., additional, Helgason, Helgi H., additional, Hendriks, Mathijs P., additional, Hoekstra, Ronald, additional, Ijzermans, Jan N.M., additional, Jansen, Jan, additional, Kloppenberg, Frank W.H., additional, Los, Maartje, additional, Meijerink, Martijn R., additional, Mekenkamp, Leonie J.M., additional, Nieboer, Peter, additional, Peeters, Koen C.M.J., additional, Peters, Natascha A.J.B., additional, Polée, Marco B., additional, Pruijt, Johannes F.M., additional, van Ufford-Mannesse, Patricia Quarles, additional, Rietbroek, Ron C., additional, Schiphorst, Anandi H.W., additional, van der Velden, Arjan Schouten, additional, Schrauwen, Ruud W.M., additional, Sie, Mark P.S., additional, Simkens, Lieke, additional, Sommeijer, Dirkje W., additional, Sonneveld, Dirk J.A., additional, Spierings, Leontine E.A., additional, Stockmann, Hein B.A.C., additional, Talsma, Koen, additional, ten Tije, Albert J., additional, Terheggen, Frederiek, additional, Tjin-A-Ton, Manuel L.R., additional, Valkenburg-van Iersel, Liselot B.J., additional, van Cruijsen, Hester, additional, Velden, Ankie M.T. van der, additional, van Dodewaard-de Jong, Joyce M., additional, van Lent, Anja U.G., additional, van Voorthuizen, Theo, additional, Vermaas, Maarten, additional, Vles, Wouter J., additional, Vogelaar, Jeroen F.J., additional, and Zimmerman, David D.E., additional

Published
2021
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15. Work Ability in Patients With Stage I to IV Colon Cancer: Results of the Dutch Prospective Colorectal Cancer Cohort

Author

Franken, Mira D., Vink, Geraldine, van Grevenstein, Wilhelmina M.U., Verkooijen, Helena M., Punt, Cornelis J.A., Koopman, Miriam, May, Anne M., Beets, Geerard L., Belt, Eric J.Th., Berbée, Maaike, Beverdam, Frederique H., Blankenburgh, Ruud, Coene, Peter Paul L.O., de Groot, Jan Willem B., de Hingh, Ignace H.J.T., de Vos, Aad I., de Wilt, Johannes H.W., Dekker, Jan Willem T., Erdkamp, Frans L.G., Haringhuizen, Annebeth W., Helgason, Helgi H., Hendriks, Mathijs P., Hoekstra, Ronald, Ijzermans, Jan N.M., Jansen, Jan, Kloppenberg, Frank W.H., Los, Maartje, Meijerink, Martijn R., Mekenkamp, Leonie J.M., Nieboer, Peter, Peeters, Koen C.M.J., Peters, Natascha A.J.B., Pruijt, Johannes F.M., van Ufford-Mannesse, Patricia Quarles, Rietbroek, Ron C., Schiphorst, Anandi H.W., Sie, Mark P.S., Simkens, Lieke H.J., Sommeijer, Dirkje W., Spierings, Leontine E.A., Stockmann, Hein B.A.C., ten Tije, Albert J., Terheggen, Frederiek, Tjin-A-Ton, Manuel L.R., Valkenburg-van Iersel, Liselot B.J., van Cruijsen, Hester, van der Velden, Ankie M.T., van Dodewaard-de Jong, Joyce M., van Lent, Anja U.G., Voorthuizen, Theo van, Vermaas, Maarten, Vles, Wouter J., Vogelaar, Jeroen F.J., and Zimmerman, David D.E.

Published
2023
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16. Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): Study protocol for a trial within a cohort study

Author

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., 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, and Oncology

Subjects
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
Abstract

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

Published
2020

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