Evidence map›Paper›PMID 32002617›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2020

A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer.

Mark Clemons, Carol Stober, Anne Kehoe, Debbie Bedard, Fiona MacDonald, Marie-Claude Brunet, Deanna Saunders, Lisa Vandermeer, Sasha Mazzarello, Arif Awan and 5 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02632435 (A Pragmatic Randomized Trial Standard of Care Vascular Access Strategies for), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
4.0field-weighted citation impact, top 5% 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.

NCT02632435 nacompletednot on this map

A Pragmatic Randomized Trial Standard of Care Vascular Access Strategies for (Neo)Adjuvant Trastuzumab-based Breast Cancer Treatment OTT 15-06 A Study From the REthinking Clinical Trials Program (REaCT-vascular Access Trastuzumab Study).

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2016 to 2019Enrolled56ConditionsBreast Cancer, CancerArmsPICC, PORT
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Implantable Ports vs Peripherally Inserted Central Catheters in Breast Cancer Chemotherapy: A Comprehensive Meta-Analysis.Medical science monitor : international medical journal of experimental and clinical research · 2025
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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

15 authors at 2 institutions in 1 country.

Mark ClemonsDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada. mclemons@toh.ca.ORCID http://orcid.org/0000-0002-0738-2713
Carol StoberCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Anne KehoeDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Debbie BedardDepartment of Nursing, Ottawa General Hospital, Ottawa, Canada.
Fiona MacDonaldDepartment of Nursing, Ottawa General Hospital, Ottawa, Canada.
Marie-Claude BrunetDepartment of Nursing, Ottawa General Hospital, Ottawa, Canada.
Deanna SaundersCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Lisa VandermeerCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Sasha MazzarelloCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Arif AwanDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Bassam BasulaimanDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
Andrew RobinsonDivision of Medical Oncology, Cancer Centre of Southeastern Ontario, Kingston, Canada.
Ranjeeta MallickDepartment of Medicine, University of Ottawa, Ottawa, Canada.
Brian HuttonClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Dean FergussonClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
University of Ottawa · CAOttawa Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTrastuzumab-based chemotherapy is usually administered through either a peripherally inserted central catheter (PICC) or a totally implanted vascular access device (PORT). As the most effective type of access is unknown, a feasibility trial, prior to conducting a large pragmatic trial, was undertaken.

methodsThe trial methodology utilized the integrated consent model incorporating oral consent. Patients receiving trastuzumab-based neo/adjuvant chemotherapy for early-stage breast cancer were randomized to a PICC or PORT insertion. Feasibility was reflected through a combination of endpoints; however, the a priori definition of feasibility was > 25% of patients approached agreed to randomization and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis.

resultsDuring the study period, 4/15 (26.7%) medical oncologists approached patients about study participation. Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8%) were randomized to PICC and 27 (48.2%) to PORT access. Overall, 17.2% (5/29) and 14.8% (4/27) of patients had at least one line-associated complication in the PICC and PORT arms respectively. The study was terminated early due to slow accrual.

conclusionThe study met its feasibility endpoints with respect to patient and physician engagement. However, the slow rate of accrual (56 patients in 2 years) means that conducting a large pragmatic trial would require additional strategies to make such a study possible.

trial registrationClinicalTrials.gov Identifier: NCT02632435.

Indexed as

Vascular Access DevicesAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarboplatinCatheterization, PeripheralCatheters, IndwellingChemotherapy, AdjuvantCyclophosphamideDocetaxelFemaleHumansMiddle AgedNeoadjuvant TherapyCarboplatinCyclophosphamideDocetaxelTrastuzumabChemotherapyTrastuzumabVascular access

Identifiers

PMID32002617
OpenAlexW3004179442

What OpenQuestion holds

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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.