Evidence map›Paper›PMID 31809876›Full record

Trial reportInternational journal of radiation oncology, biology, physics2020

Long-Term Results from the IDEAL-CRT Phase 1/2 Trial of Isotoxically Dose-Escalated Radiation Therapy and Concurrent Chemotherapy for Stage II/III Non-small Cell Lung Cancer.

John D Fenwick, David B Landau, Angela T Baker, Andrew T Bates, Chinnamani Eswar, Angel Garcia-Alonso, Susan V Harden, Marianne C Illsley, Virginia Laurence, Zafar Malik and 11 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

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

10 citing papers in PubMed.

  1. Article
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  6. Review
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  10. 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

21 authors.

John D FenwickDepartment of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, University of Liverpool, Liverpool, United Kingdom.
David B LandauGuy's & St. Thomas' NHS Foundation Trust, London, United Kingdom. Electronic address: dblandau@gmail.com.
Angela T BakerOxford Cancer Centre, Oxford, United Kingdom.
Andrew T BatesUniversity Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
Chinnamani EswarThe Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, United Kingdom.
Angel Garcia-AlonsoNorth Wales Cancer Treatment Centre, Rhyl, United Kingdom.
Susan V HardenAddenbrookes Hospital, Cambridge, United Kingdom.
Marianne C IllsleyRoyal Surrey County Hospital NHS Foundation Trust, Guildford, United Kingdom.
Virginia LaurencePoole Hospital NHS Foundation Trust, Poole, United Kingdom.
Zafar MalikThe Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, United Kingdom.
William Philip M MaylesThe Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, United Kingdom.
Elizabeth MilesRadiotherapy Trials Quality Assurance Group, Mount Vernon Cancer Centre, Middlesex, United Kingdom.
Nazia MohammedBeatson West of Scotland Cancer Centre, Glasgow, United Kingdom.
James SpicerGuy's & St. Thomas' NHS Foundation Trust, London, United Kingdom.
Paula WellsBarts Health NHS Trust, London, United Kingdom.
Sindu VivekanandanGuy's & St. Thomas' NHS Foundation Trust, London, United Kingdom.
Anne-Marie MullinCancer Research UK & University College London Cancer Trials Centre, London, United Kingdom.
Laura HughesCancer Research UK & University College London Cancer Trials Centre, London, United Kingdom.
Laura FarrellyCancer Research UK & University College London Cancer Trials Centre, London, United Kingdom.
Yenting NgaiCancer Research UK & University College London Cancer Trials Centre, London, United Kingdom.
Nicholas CounsellCancer Research UK & University College London Cancer Trials Centre, London, United Kingdom.

Funding

Cancer Research UK 8313Cancer Research UK C13530/A10424Cancer Research UK C13530/A17007
6 · The paper itself

Abstract

purposeThe IDEAL-CRT phase 1/2 multicenter trial of isotoxically dose-escalated concurrent chemoradiation for stage II/III non-small cell lung cancer investigated two 30-fraction schedules of 5 and 6 weeks' duration. We report toxicity, tumor response, progression-free survival (PFS), and overall survival (OS) for both schedules, with long-term follow-up for the 6-week schedule. METHODS AND MATERIALS: Patients received isotoxically individualized tumor radiation doses of 63 to 71 Gy in 5 weeks or 63 to 73 Gy in 6 weeks, delivered concurrently with 2 cycles of cisplatin and vinorelbine. Eligibility criteria were the same for both schedules.

resultsOne-hundred twenty patients (6% stage IIB, 68% IIIA, 26% IIIB, 1% IV) were recruited from 9 UK centers, 118 starting treatment. Median prescribed doses were 64.5 and 67.6 Gy for the 36 and 82 patients treated using the 5- and 6-week schedules. Grade ≥3 pneumonitis and early esophagitis rates were 3.4% and 5.9% overall and similar for each schedule individually. Late grade 2 esophageal toxicity occurred in 11.1% and 17.1% of 5- and 6-week patients. Grade ≥4 adverse events occurred in 17 (20.7%) 6-week patients but no 5-week patients. Four adverse events were grade 5, with 2 considered radiation therapy related. After median follow-up of 51.8 and 26.4 months for the 6- and 5-week schedules, median OS was 41.2 and 22.1 months, respectively, and median PFS was 21.1 and 8.0 months. In exploratory analyses, OS was significantly associated with schedule (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.32-0.98; P = .04) and fractional clinical/internal target volume receiving ≥95% of the prescribed dose (HR, 0.88; 95% CI, 0.77-1.00; P = .05). PFS was also significantly associated with schedule (HR, 0.53; 95% CI, 0.33-0.86; P = .01).

conclusionsToxicity in IDEAL-CRT was acceptable. Survival was promising for 6-week patients and significantly longer than for 5-week patients. Survival might be further lengthened by following the 6-week schedule with an immune agent, motivating further study of such combined optimized treatments.

Indexed as

AdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungChemoradiotherapyDose Fractionation, RadiationDose-Response Relationship, RadiationFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingTime FactorsTreatment Outcome

Identifiers

PMID31809876
PMCPMC7049901

What OpenQuestion holds

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Registered trials

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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.