Evidence map›Paper›PMID 21569373›Full record

Trial reportBMC surgery2011

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

Daniel J Lips, Boukje Koebrugge, Gerrit Jan Liefers, Johannes C van de Linden, Vincent T H B M Smit, Hans F M Pruijt, Hein Putter, Cornelis J H van de Velde, Koop Bosscha

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC surgery, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01097265 (The Influence of Micrometastases on Prognosis and Survival in Stage I-II Colon Cancer Patients), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.4field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01097265 phase2 / phase3unknown statusnot on this map

The Influence of Micrometastases on Prognosis and Survival in Stage I-II Colon Cancer Patients: The EnRoute+ Study

TypeinterventionalSponsorJeroen Bosch ZiekenhuisRan2010Enrolled1,500ConditionsColorectal CancerArmscapecitabine, oxaliplatin, active surveillance, laboratory biomarker analysis, adjuvant therapy
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 51 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Daniel J LipsDepartment of Surgery, Jeroen Bosch Hospital, Nieuwstraat 34, 5211 NL 's-Hertogenbosch, The Netherlands. djlips@home.nl
Boukje Koebrugge
Gerrit Jan Liefers
Johannes C van de Linden
Vincent T H B M Smit
Hans F M Pruijt
Hein Putter
Cornelis J H van de Velde
Koop Bosscha
Leiden University Medical Center · NLJeroen Bosch Ziekenhuis · NLRobert Bosch (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 pN0(micro+) 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(micro+)) and evaluate the benefits from adjuvant chemotherapy in pN0(micro+) 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 (pN0(micro+)) 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 registrationClinicalTrials.gov: NCT01097265.

Indexed as

AdultAgedAged, 80 and overChemotherapy, AdjuvantClinical ProtocolsColonic NeoplasmsDisease-Free SurvivalFemaleHumansLymphatic MetastasisMaleMiddle AgedNeoplasm StagingPrognosisSentinel Lymph Node Biopsy

Identifiers

PMID21569373
PMCPMC3123166
OpenAlexW2072043025

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.