Evidence map›Paper›PMID 28376151›Full record

Trial reportJournal of the National Cancer Institute2017

Local Treatment of Unresectable Colorectal Liver Metastases: Results of a Randomized Phase II Trial.

Theo Ruers, Frits Van Coevorden, Cornelis J A Punt, Jean-Pierre E N Pierie, Inne Borel-Rinkes, Jonathan A Ledermann, Graeme Poston, Wolf Bechstein, Marie-Ange Lentz, Murielle Mauer and 8 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 300 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
300citing papers in PubMed, 8 pooled it
–field-weighted citation impact
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.

NCT03686254 phase2 / phase3unknown statusnot on this mapstarted 2018, after this paper: background citation

The Effect and Safety on Unresectable CRLM From RFA in Combination With Second-line Chemotherapy and Bevacizumab Compared With the Combination of Second-line Chemotherapy and Bevacizumab: a Randomized and Controlled Clinical Trial

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2018 to 2023Enrolled160ConditionsColorectal Neoplasms MalignantArmsRFA, bevacizumab and second-line chemotherapy, Bevacizumab and second-line chemotherapy
NCT03862911 naactive not recruitingnot on this mapstarted 2019, after this paper: background citation

Phase III Randomized Controlled Trial and Economic Evaluation of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic (1-3 Metastases) Cancer (SABR-COMET-3)

TypeinterventionalSponsorBritish Columbia Cancer AgencyRan2019 to 2030Enrolled330ConditionsMetastatic TumorsArmspalliative radiotherapy, Stereotactic ablative radiotherapy
NCT06416436 phase1withdrawnnot on this mapstarted 2024, after this paper: background citation

Immunotherapy in Combination With Ablative Radiosurgery to Ultra-high DoSes (ICARUS): A Phase I Dose-escalation Radiosurgery Study in Metastatic Cancers

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2024 to 2024Enrolled0ConditionsSolid TumorArmsAtezolizumab, Stereotactic Ablative Radiotherapy (SBRT)
3 · Its place in the literature

Who cites it

300 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  8. Missing colorectal liver metastases: the surgical challenge.Langenbeck's archives of surgery · 2021
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240 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Theo RuersNetherlands Cancer Institute, Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, The Netherlands.
Frits Van CoevordenNetherlands Cancer Institute, Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, The Netherlands.
Cornelis J A PuntAcademic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Jean-Pierre E N PierieLeeuwarden Medical Center, Leeuwarden, The Netherlands.
Inne Borel-RinkesUniversitair Medisch Centrum, Academisch Ziekenhuis, Utrecht, The Netherlands.
Jonathan A LedermannCancer Research UK and UCL Cancer Trials Centre and UCL Hospitals, London, United Kingdom.
Graeme PostonAintree University Hospital, Liverpool, United Kingdom.
Wolf BechsteinFrankfurt University Hospital and Clinics, Frankfurt, Germany.
Marie-Ange LentzEORTC Headquarters, Data Management Unit, Brussels, Belgium.
Murielle MauerEORTC Headquarters, Statistics Department, Brussels, Belgium.
Gunnar FolprechtUniversity Cancer Center, University Hospital Carl Gustav Carus, Dresden, Germany.
Eric Van CutsemDigestive Oncology, University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium.
Michel DucreuxInstitut Gustave Roussy, Villejuif, France.
Bernard NordlingerAssistance Publique Hôpitaux de Paris, Boulogne-Billancourt, France.
European Organisation for Research and Treatment of Cancer (EORTC)
Gastro-Intestinal Tract Cancer Group
Arbeitsgruppe Lebermetastasen und tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO)
National Cancer Research Institute Colorectal Clinical Study Group (NCRI CCSG)

Funding

EORTC HEADQUARTERSU10CA011488 · NCI · EUROPEAN ORG/RES/TREATMENT/CANCER · PI LACOMBE, DENIS · 1985 to 2015
$6.6M
NCI NIH HHS U10 CA011488
6 · The paper itself

Abstract

Background: Tumor ablation is often employed for unresectable colorectal liver metastases. However, no survival benefit has ever been demonstrated in prospective randomized studies. Here, we investigate the long-term benefits of such an aggressive approach. Methods: In this randomized phase II trial, 119 patients with unresectable colorectal liver metastases (n < 10 and no extrahepatic disease) received systemic treatment alone or systemic treatment plus aggressive local treatment by radiofrequency ablation ± resection. Previously, we reported that the primary end point (30-month overall survival [OS] > 38%) was met. We now report on long-term OS results. All statistical tests were two-sided. The analyses were according to intention to treat. Results: At a median follow up of 9.7 years, 92 of 119 (77.3%) patients had died: 39 of 60 (65.0%) in the combined modality arm and 53 of 59 (89.8%) in the systemic treatment arm. Almost all patients died of progressive disease (35 patients in the combined modality arm, 49 patients in the systemic treatment arm). There was a statistically significant difference in OS in favor of the combined modality arm (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.38 to 0.88, P = .01). Three-, five-, and eight-year OS were 56.9% (95% CI = 43.3% to 68.5%), 43.1% (95% CI = 30.3% to 55.3%), 35.9% (95% CI = 23.8% to 48.2%), respectively, in the combined modality arm and 55.2% (95% CI = 41.6% to 66.9%), 30.3% (95% CI = 19.0% to 42.4%), 8.9% (95% CI = 3.3% to 18.1%), respectively, in the systemic treatment arm. Median OS was 45.6 months (95% CI = 30.3 to 67.8 months) in the combined modality arm vs 40.5 months (95% CI = 27.5 to 47.7 months) in the systemic treatment arm. Conclusions: This phase II trial is the first randomized study demonstrating that aggressive local treatment can prolong OS in patients with unresectable colorectal liver metastases.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCatheter AblationChemotherapy, AdjuvantColorectal NeoplasmsDisease-Free SurvivalFluorouracilHumansLeucovorinLiver NeoplasmsMiddle AgedNeoplasm StagingOrganoplatinum CompoundsOxaliplatinFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID28376151
PMCPMC5408999

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.