The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute<it>⊕ </it>Study
<p>Abstract</p> <p>Background</p> <p>The presence of lymph node metastases remains the most reliable prognostic predictor and the gold indicator for adjuvant treatment in colon cancer (CC). In spite of a potentially curative resection, 20 to 30% of CC patients testing n...
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| Format: | Article |
| Language: | English |
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BMC
2011-05-01
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| Series: | BMC Surgery |
| Online Access: | http://www.biomedcentral.com/1471-2482/11/11 |
| _version_ | 1818335059894075392 |
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| author | Pruijt Hans FM Smit Vincent THBM van de Linden Johannes C Jan Liefers Gerrit Koebrugge Boukje Lips Daniel J Putter Hein van de Velde Cornelis JH Bosscha Koop |
| author_facet | Pruijt Hans FM Smit Vincent THBM van de Linden Johannes C Jan Liefers Gerrit Koebrugge Boukje Lips Daniel J Putter Hein van de Velde Cornelis JH Bosscha Koop |
| author_sort | Pruijt Hans FM |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>The presence of lymph node metastases remains the most reliable prognostic predictor and the gold indicator for adjuvant treatment in colon cancer (CC). In spite of a potentially curative resection, 20 to 30% of CC patients testing negative for lymph node metastases (i.e. pN0) will subsequently develop locoregional and/or systemic metastases within 5 years. The presence of occult nodal isolated tumor cells (ITCs) and/or micrometastases (MMs) at the time of resection predisposes CC patients to high risk for disease recurrence. These pN0<sub>micro+ </sub>patients harbouring occult micrometastases may benefit from adjuvant treatment. The purpose of the present study is to delineate the subset of pN0 patients with micrometastases (pN0<sub>micro+</sub>) and evaluate the benefits from adjuvant chemotherapy in pN0<sub>micro+ </sub>CC patients.</p> <p>Methods/design</p> <p>EnRoute+ is an open label, multicenter, randomized controlled clinical trial. All CC patients (age above 18 years) without synchronous locoregional lymph node and/or systemic metastases (clinical stage I-II disease) and operated upon with curative intent are eligible for inclusion. All resected specimens of patients are subject to an <it>ex vivo </it>sentinel lymph node mapping procedure (SLNM) following curative resection. The investigation for micrometastases in pN0 patients is done by extended serial sectioning and immunohistochemistry for pan-cytokeratin in sentinel lymph nodes which are tumour negative upon standard pathological examination. Patients with ITC/MM-positive sentinel lymph nodes (pN0<sub>micro+</sub>) are randomized for adjuvant chemotherapy following the CAPOX treatment scheme or observation. The primary endpoint is 3-year disease free survival (DFS).</p> <p>Discussion</p> <p>The EnRoute+ study is designed to improve prognosis in high-risk stage I/II pN0 <sub>micro+ </sub>CC patients by reducing disease recurrence by adjuvant chemotherapy.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01097265">NCT01097265</a></p> |
| first_indexed | 2024-12-13T14:17:25Z |
| format | Article |
| id | doaj.art-0a1857ad63764bdfb77f074cc07052d0 |
| institution | Directory Open Access Journal |
| issn | 1471-2482 |
| language | English |
| last_indexed | 2024-12-13T14:17:25Z |
| publishDate | 2011-05-01 |
| publisher | BMC |
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| series | BMC Surgery |
| spelling | doaj.art-0a1857ad63764bdfb77f074cc07052d02022-12-21T23:42:15ZengBMCBMC Surgery1471-24822011-05-011111110.1186/1471-2482-11-11The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute<it>⊕ </it>StudyPruijt Hans FMSmit Vincent THBMvan de Linden Johannes CJan Liefers GerritKoebrugge BoukjeLips Daniel JPutter Heinvan de Velde Cornelis JHBosscha Koop<p>Abstract</p> <p>Background</p> <p>The presence of lymph node metastases remains the most reliable prognostic predictor and the gold indicator for adjuvant treatment in colon cancer (CC). In spite of a potentially curative resection, 20 to 30% of CC patients testing negative for lymph node metastases (i.e. pN0) will subsequently develop locoregional and/or systemic metastases within 5 years. The presence of occult nodal isolated tumor cells (ITCs) and/or micrometastases (MMs) at the time of resection predisposes CC patients to high risk for disease recurrence. These pN0<sub>micro+ </sub>patients harbouring occult micrometastases may benefit from adjuvant treatment. The purpose of the present study is to delineate the subset of pN0 patients with micrometastases (pN0<sub>micro+</sub>) and evaluate the benefits from adjuvant chemotherapy in pN0<sub>micro+ </sub>CC patients.</p> <p>Methods/design</p> <p>EnRoute+ is an open label, multicenter, randomized controlled clinical trial. All CC patients (age above 18 years) without synchronous locoregional lymph node and/or systemic metastases (clinical stage I-II disease) and operated upon with curative intent are eligible for inclusion. All resected specimens of patients are subject to an <it>ex vivo </it>sentinel lymph node mapping procedure (SLNM) following curative resection. The investigation for micrometastases in pN0 patients is done by extended serial sectioning and immunohistochemistry for pan-cytokeratin in sentinel lymph nodes which are tumour negative upon standard pathological examination. Patients with ITC/MM-positive sentinel lymph nodes (pN0<sub>micro+</sub>) are randomized for adjuvant chemotherapy following the CAPOX treatment scheme or observation. The primary endpoint is 3-year disease free survival (DFS).</p> <p>Discussion</p> <p>The EnRoute+ study is designed to improve prognosis in high-risk stage I/II pN0 <sub>micro+ </sub>CC patients by reducing disease recurrence by adjuvant chemotherapy.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01097265">NCT01097265</a></p>http://www.biomedcentral.com/1471-2482/11/11 |
| spellingShingle | Pruijt Hans FM Smit Vincent THBM van de Linden Johannes C Jan Liefers Gerrit Koebrugge Boukje Lips Daniel J Putter Hein van de Velde Cornelis JH Bosscha Koop The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute<it>⊕ </it>Study BMC Surgery |
| title | The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute<it>⊕ </it>Study |
| title_full | The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute<it>⊕ </it>Study |
| title_fullStr | The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute<it>⊕ </it>Study |
| title_full_unstemmed | The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute<it>⊕ </it>Study |
| title_short | The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute<it>⊕ </it>Study |
| title_sort | influence of micrometastases on prognosis and survival in stage i ii colon cancer patients the enroute it ⊕ it study |
| url | http://www.biomedcentral.com/1471-2482/11/11 |
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