التفاصيل البيبلوغرافية
| العنوان: |
Improving clinical management of colon cancer through CONNECTION, a nation-wide colon cancer registry and stratification effort (CONNECTION II trial): rationale and protocol of a single arm intervention study |
| المؤلفون: |
I. van den Berg, S. van de Weerd, J. M. L. Roodhart, G. R. Vink, R. R. J. Coebergh van den Braak, C. R. Jimenez, S. G. Elias, D. van Vliet, M. Koelink, E. Hong, W. M. U. van Grevenstein, M. G. H. van Oijen, R. G. H. Beets-Tan, J. H. J. M. van Krieken, J. N. M. IJzermans, J. P. Medema, M. Koopman, on behalf of the CONNECTION-study group |
| المصدر: |
BMC Cancer, Vol 20, Iss 1, Pp 1-8 (2020) |
| بيانات النشر: |
BMC, 2020. |
| سنة النشر: |
2020 |
| المجموعة: |
LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens |
| مصطلحات موضوعية: |
Colon cancer, Consensus molecular subtypes, Neoadjuvant chemotherapy, Surgery, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282 |
| الوصف: |
Abstract Background It is estimated that around 15–30% of patients with early stage colon cancer benefit from adjuvant chemotherapy. We are currently not capable of upfront selection of patients who benefit from chemotherapy, which indicates the need for additional predictive markers for response to chemotherapy. It has been shown that the consensus molecular subtypes (CMSs), defined by RNA-profiling, have prognostic and/or predictive value. Due to postoperative timing of chemotherapy in current guidelines, tumor response to chemotherapy per CMS is not known, which makes the differentiation between the prognostic and predictive value impossible. Therefore, we propose to assess the tumor response per CMS in the neoadjuvant chemotherapy setting. This will provide us with clear data on the predictive value for chemotherapy response of the CMSs. Methods In this prospective, single arm, multicenter intervention study, 262 patients with resectable microsatellite stable cT3–4NxM0 colon cancer will be treated with two courses of neoadjuvant and two courses of adjuvant capecitabine and oxaliplatin. The primary endpoint is the pathological tumor response to neoadjuvant chemotherapy per CMS. Secondary endpoints are radiological tumor response, the prognostic value of these responses for recurrence free survival and overall survival and the differences in CMS classification of the same tumor before and after neoadjuvant chemotherapy. The study is scheduled to be performed in 8–10 Dutch hospitals. The first patient was included in February 2020. Discussion Patient selection for adjuvant chemotherapy in early stage colon cancer is far from optimal. The CMS classification is a promising new biomarker, but a solid chemotherapy response assessment per subtype is lacking. In this study we will investigate whether CMS classification can be of added value in clinical decision making by analyzing the predictive value for chemotherapy response. This study can provide the results necessary to proceed to future studies in which (neo) adjuvant chemotherapy may be withhold in patients with a specific CMS subtype, who show no benefit from chemotherapy and for whom possible new treatments can be investigated. Trial registration This study has been registered in the Netherlands Trial Register (NL8177) at 11–26-2019, https://www.trialregister.nl/trial/8177 . The study has been approved by the medical ethics committee Utrecht (MEC18/712). |
| نوع الوثيقة: |
article |
| وصف الملف: |
electronic resource |
| اللغة: |
English |
| تدمد: |
1471-2407 |
| Relation: |
http://link.springer.com/article/10.1186/s12885-020-07236-y; https://doaj.org/toc/1471-2407 |
| DOI: |
10.1186/s12885-020-07236-y |
| URL الوصول: |
https://doaj.org/article/163502d3031c4183ab66a5aca4dd2ae9 |
| رقم الانضمام: |
edsdoj.163502d3031c4183ab66a5aca4dd2ae9 |
| قاعدة البيانات: |
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