Evidence map›Paper›PMID 25487708›Full record

Trial reportBMC cancer2014

Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study.

Peter Gibbs, Val Gebski, Mark Van Buskirk, Kenneth Thurston, David N Cade, Guy A Van Hazel, SIRFLOX Study Group

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

Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00724503 (Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing 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.

NCT00724503 nacompletednot on this map

Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

TypeinterventionalSponsorSirtex MedicalRan2006 to 2015Enrolled530ConditionsColorectal Cancer, Colorectal Carcinoma, Liver MetastasesArmsSIR-Spheres yttrium-90 microspheres, Systemic chemotherapy (FOLFOX)
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 62 citations in OpenAlex.

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  5. The Future of Interventions for Stage IV Colorectal Cancers.Clinics in colon and rectal surgery · 2024
    Review
  6. New frontiers in radioembolization.Therapeutic advances in medical oncology · 2024
    Review
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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

7 authors at 4 institutions in 2 countries.

Peter GibbsRoyal Melbourne Hospital, Melbourne, Victoria, Australia. peter.gibbs@mh.org.au.
Val Gebski
Mark Van Buskirk
Kenneth Thurston
David N Cade
Guy A Van Hazel
SIRFLOX Study Group
Sirtex (Australia) · AUThe Royal Melbourne Hospital · AUCooperative Trials Group for Neuro-Oncology · AUThe University of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn colorectal cancer (CRC), unresectable liver metastases are linked to poor prognosis. Systemic chemotherapy with regimens such as FOLFOX (combination of infusional 5-fluorouracil, leucovorin and oxaliplatin) is the standard first-line treatment. The SIRFLOX trial was designed to assess the efficacy and safety of combining FOLFOX-based chemotherapy with Selective Internal Radiation Therapy (SIRT or radioembolisation) using yttrium-90 resin microspheres (SIR-SpheresR; Sirtex Medical Limited, North Sydney, Australia). METHODS/

designSIRFLOX is a randomised, multicentre trial of mFOLFOX6 chemotherapy+/-SIRT as first-line treatment of patients with liver-only or liver-predominant metastatic CRC (mCRC). The trial aims to recruit adult chemotherapy-naive patients with proven liver metastases with or without limited extra-hepatic disease, a life expectancy of >=3 months and a WHO performance status of 0-1. Patients will be randomised to receive either mFOLFOX6 or SIRT+mFOLFOX6 (with a reduced dose of oxaliplatin in cycles 1-3 following SIRT). Patients in both arms can receive bevacizumab at investigator discretion. Protocol chemotherapy will continue until there is unacceptable toxicity, evidence of tumour progression, complete surgical resection or ablation of cancerous lesions, or the patient requests an end to treatment. The primary endpoint of the SIRFLOX trial is progression-free survival (PFS). Secondary endpoints include: PFS in the liver; tumour response rate (liver and any site); site of tumour progression; health-related quality of life; toxicity and safety; liver resection rate; and overall survival. Assuming an increase in the median PFS from 9.4 months to 12.5 months with the addition of SIRT to mFOLFOX6, recruiting >=450 patients will be sufficient for 80% power and 95% confidence. DISCUSSION: The SIRFLOX trial will establish the potential role of SIRT+standard systemic chemotherapy in the first-line management of mCRC with non-resectable liver metastases.

trial registrationSIRFLOX ClinicalTrials.gov identifier: NCT00724503. Registered 25 July 2008.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyColorectal NeoplasmsFluorouracilHumansLeucovorinLiver NeoplasmsMicrospheresOrganoplatinum CompoundsYttrium RadioisotopesFluorouracilLeucovorinOrganoplatinum CompoundsYttrium Radioisotopes

Identifiers

PMID25487708
PMCPMC4289171
OpenAlexW2098964416

What OpenQuestion holds

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LicenceCC BY
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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.