The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute⊕ Study

BMC Surgery

Study Protocol

Hans FM Pruijt¹  Hein Putter²  Johannes C van de Linden³  Vincent THBM Smit⁴  Daniel J Lips⁵  Koop Bosscha⁵  Boukje Koebrugge⁶  Cornelis JH van de Velde⁷  Gerrit Jan Liefers⁷ 

[1] Department of Medical Oncology, Jeroen Bosch Hospital, Nieuwstraat 34, 5211, 's-Hertogenbosch, NL, The Netherlands;Department of Medical Statistics, Leiden University Medical Center, PO Box 9600, 2300, Leiden, RC, The Netherlands;Department of Pathology, Jeroen Bosch Hospital, Nieuwstraat 34, 5211, 's-Hertogenbosch, NL, The Netherlands;Department of Pathology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands;Department of Surgery, Jeroen Bosch Hospital, Nieuwstraat 34, 5211, NL, 's-Hertogenbosch, The Netherlands;Department of Surgery, Jeroen Bosch Hospital, Nieuwstraat 34, 5211, NL, 's-Hertogenbosch, The Netherlands;Department of Surgery, Leiden University Medical Center, PO Box 9600, 2300, Leiden, RC, The Netherlands;Department of Surgery, Leiden University Medical Center, PO Box 9600, 2300, Leiden, RC, The Netherlands;

关键词: Overall Survival;    Sentinel Lymph Node;    Adjuvant Chemotherapy;    Disease Free Survival;    Colon Cancer Patient;   

DOI  :  10.1186/1471-2482-11-11

 received in 2010-10-03, accepted in 2011-05-11,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundThe 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/designEnRoute+ 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).DiscussionThe 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 RegistrationClinicalTrials.gov: NCT01097265

【 授权许可】

CC BY   
© Lips et al; licensee BioMed Central Ltd. 2011