Evidence map›Paper›PMID 25211659›Full record

Trial reportBritish journal of cancer2014

Phase II trial evaluating the feasibility of interdigitating folfox with chemoradiotherapy in locally advanced and metastatic rectal cancer.

M Michael, S Chander, J McKendrick, J R MacKay, M Steel, R Hicks, A Heriot, T Leong, P Cooray, M Jefford and 4 more

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 9 citations in OpenAlex.

No citing paper in PubMed yet.

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

14 authors at 3 institutions in 1 country.

M Michael1] Division of Cancer Medicine, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia [2] The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Melbourne, Victoria, Australia.
S ChanderDivision of Radiation Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
J McKendrickDepartment of Medical Oncology, Box Hill Hospital, Melbourne, Victoria, Australia.
J R MacKayDivision of Surgical Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
M SteelDepartment of Surgery, Box Hill Hospital, Melbourne, Victoria, Australia.
R Hicks1] The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Melbourne, Victoria, Australia [2] Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
A HeriotDivision of Surgical Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
T LeongDivision of Radiation Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
P CoorayDepartment of Medical Oncology, Box Hill Hospital, Melbourne, Victoria, Australia.
M Jefford1] Division of Cancer Medicine, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia [2] The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Melbourne, Victoria, Australia.
J ZalcbergDivision of Cancer Medicine, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
M BresselCentre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
B McClureCentre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
S Y NganDivision of Radiation Oncology, Lower Gastrointestinal Tumour Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Peter MacCallum Cancer Centre · AUBox Hill Hospital · AUUniversity of Melbourne · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients (pts) with metastatic rectal cancer and symptomatic primary, require local and systemic control. Chemotherapy used during chemoradiotherapy (CRT) is adequate for radiosensitisation, but suboptimal for systemic control. The aim of this phase II study was to assess tolerability, local/systemic benefits, of a novel regimen delivering interdigitating intensive chemotherapy with radical CRT.

methodsEligible pts had untreated synchronous symptomatic primary/metastatic rectal cancer. A total of 12 weeks of treatment with split-course pelvic CRT (total 50.4 Gy with concurrent oxaliplatin and 5-FU infusion) alternating with FOLFOX chemotherapy. All pts staged with CT, MRI and FDG-PET pre and post treatment.

resultsTwenty-six pts were treated. Rectal primary MRI stage: T3 81% and T4 15%. Liver metastases in 81%. Twenty-four pts (92%) completed the 12-week regimen. All patients received planned RT dose, and for both agents over 88% of patients achieved a relative dose intensity of >75%. Grade 3 toxicities: neutropenia 23%, diarrhoea 15%, and radiation skin reaction 12%. Grade 4 toxicity: neutropenia 15%. FDG-PET metabolic response rate for rectal primary 96%, and for metastatic disease 60%.

conclusionsDelivery of interdigitating chemotherapy with radical CRT was feasible to treat both primary and metastatic rectal cancer. High completion and response rates were encouraging.

Indexed as

ChemoradiotherapyAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCohort StudiesFeasibility StudiesFemaleFluorouracilFollow-Up StudiesHumansLeucovorinLiver NeoplasmsLung NeoplasmsMaleFluorouracilLeucovorinOrganoplatinum CompoundsOxaliplatin

Identifiers

PMID25211659
PMCPMC4229632
OpenAlexW2030140843

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

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.