Evidence map›Paper›PMID 31382986›Full record

Trial reportTrials2019

Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan.

Serigne N Lo, Angela M Hong, Lauren E Haydu, Tasnia Ahmed, Elizabeth J Paton, Victoria Steel, George Hruby, Anh Tran, Rachael L Morton, Anna K Nowak and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01503827 (Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT01503827 naunknown statusnot on this map

Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma - A Randomised Phase III Trial

TypeinterventionalSponsorMelanoma and Skin Cancer Trials LimitedRan2007 to 2022Enrolled220ConditionsMetastatic MelanomaArmsWBRT
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
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

19 authors.

Serigne N LoMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Angela M HongMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Lauren E HayduMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Tasnia AhmedMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Elizabeth J PatonSydney Medical School, The University of Sydney, Sydney, NSW, Australia.
Victoria SteelSydney Medical School, The University of Sydney, Sydney, NSW, Australia.
George HrubySydney Medical School, The University of Sydney, Sydney, NSW, Australia.
Anh TranMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Rachael L MortonMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Anna K NowakMedical School, University of Western Australia, Perth, WA, Australia.
Janette L VardySydney Medical School, The University of Sydney, Sydney, NSW, Australia.
Katharine J DrummondRoyal Melbourne Hospital, Parkville, VIC, Australia.
Haryana M DhillonSydney Medical School, The University of Sydney, Sydney, NSW, Australia.
Catherine MandelSwinburne University of Technology, Melbourne, VIC, Australia.
Richard A ScolyerMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Mark R MiddletonUniversity of Oxford, Oxford, UK.
Bryan H BurmeisterGenesis Care Fraser Coast, Urraween, QLD, Australia.
John F ThompsonMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.
Gerald B FogartyMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia. gerald.fogarty@cancer.com.au.ORCID http://orcid.org/0000-0002-0764-578X

Funding

Cancer Australia 1084046Cancer Research UK 11885
6 · The paper itself

Abstract

backgroundThe WBRTMel trial is a multinational, open-label, phase III randomised controlled trial comparing whole brain radiotherapy (WBRT) to observation following local treatment of one to three melanoma brain metastases with surgery and/or stereotactic irradiation. The primary trial endpoint was to determine the effect of adding WBRT to local treatment on distant intracranial control, and the secondary endpoints were neurocognitive function, quality of life (QoL), performance status, overall survival, death from intracranial causes, death from melanoma and cost-effectiveness.

objectiveThe objective of this update is to outline and publish the pre-determined statistical analysis plan (SAP) before the database lock and the start of analysis.

methodsThe SAP describes basic analysis principles, methods for dealing with a range of commonly encountered data analysis issues and the specific statistical procedures for analysing efficacy and safety outcomes. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses regarding the clinical and QoL outcomes. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid analysis bias arising from knowledge of the data.

resultsThe resulting SAP is consistent with best practice and will allow open and transparent reporting.

conclusionWe have developed a SAP for the WBRTMel trial which will be followed to ensure high-quality standards of internal validity to minimise analysis bias.

trial registrationANZ Clinical Trials Registry, ACTRN12607000512426 . Registered on 9 October 2007. ClinicalTrials.gov, NCT01503827 . Registered on 4 January 2012. Trial group reference numbers ANZMTG 01.07, TROG 08.05.

Indexed as

Cranial IrradiationData Interpretation, StatisticalBrain NeoplasmsFemaleHumansMaleMelanomaOutcome Assessment, Health CareQuality of LifeResearch DesignSample SizeBrainMelanomaMetastasesRadiotherapyRandomised trialWhole brain radiotherapy

Identifiers

PMID31382986
PMCPMC6683544

What OpenQuestion holds

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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.