The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute circle plus Study
| Autor: | Hein Putter, Hans Pruijt, B. Koebrugge, Koop Bosscha, Vincent T.H.B.M. Smit, Gerrit-Jan Liefers, Cornelis J.H. van de Velde, Johannes C van de Linden, D.J. Lips |
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| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Colorectal cancer medicine.medical_treatment lcsh:Surgery Disease-Free Survival Study Protocol Clinical Protocols Internal medicine medicine Clinical endpoint Humans Stage (cooking) Lymph node Aged Neoplasm Staging Aged 80 and over Chemotherapy business.industry Sentinel Lymph Node Biopsy General Medicine lcsh:RD1-811 Middle Aged medicine.disease Prognosis Clinical trial medicine.anatomical_structure Chemotherapy Adjuvant Lymphatic Metastasis Colonic Neoplasms Surgery Female Lymph business Adjuvant |
| Zdroj: | BMC Surgery, 11 BMC Surgery BMC Surgery, Vol 11, Iss 1, p 11 (2011) |
| Popis: | Background 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 pN0micro+ 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 (pN0micro+) and evaluate the benefits from adjuvant chemotherapy in pN0micro+ CC patients. Methods/design 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 ex vivo 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 (pN0micro+) are randomized for adjuvant chemotherapy following the CAPOX treatment scheme or observation. The primary endpoint is 3-year disease free survival (DFS). Discussion The EnRoute+ study is designed to improve prognosis in high-risk stage I/II pN0 micro+ CC patients by reducing disease recurrence by adjuvant chemotherapy. Trial Registration ClinicalTrials.gov: NCT01097265 |
| Databáze: | OpenAIRE |
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