Evidence map›Paper›PMID 32169590›Full record

Trial reportPractical radiation oncology

A Prospective Multi-Institutional Phase I/II Trial of Step-Wise Dose-per-Fraction Escalation in Low and Intermediate Risk Prostate Cancer.

Mark A Ritter, Patrick A Kupelian, Daniel G Petereit, Colleen A Lawton, Nick Anger, Heather Geye, Richard J Chappell, Jeffrey D Forman

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Practical radiation oncology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.1field-weighted citation impact, top 51% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
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

8 authors at 5 institutions in 1 country.

Mark A RitterDepartment of Human Oncology, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. Electronic address: ritter@humonc.wisc.edu.
Patrick A KupelianUCLA Medical Center, Los Angeles, California.
Daniel G PetereitJohn T. Vucurevich Cancer Center Institute, Rapid City, South Dakota.
Colleen A LawtonMedical College of Wisconsin, Milwaukee, Wisconsin.
Nick AngerDepartment of Human Oncology, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.
Heather GeyeDepartment of Human Oncology, University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.
Richard J ChappellDepartment of Biostatistics and Medical Informatics and Department of Statistics, University of Wisconsin, Madison, Wisconsin.
Jeffrey D FormanKarmanos Cancer Institute, Detroit, Michigan.
University of Wisconsin Carbone Cancer Center · USMedical College of Wisconsin · USRonald Reagan UCLA Medical Center · USThe Barbara Ann Karmanos Cancer Institute · USUniversity of Wisconsin–Madison · US

Funding

Hypofractionated IMRT for Localized Prostate CancerR01CA106835 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI RITTER, MARK A · 2005 to 2008
$940k
NCI NIH HHS R01 CA106835
6 · The paper itself

Abstract

purposeThis phase I/II, multi-institutional trial explored the tolerance and efficacy of stepwise increasing hypofractionation (HPFX) radiation therapy regimens for fraction sizes up to 4.3 Gy in localized prostate cancer. METHODS AND MATERIALS: Three escalating dose-per-fraction schedules were designed to yield similar predicted tumor control while maintaining equivalent predicted late toxicity. HPFX levels I, II, and III were carried out sequentially and delivered schedules of 64.7 Gy/22 fx/2.94 Gy, 58.08 Gy/16 fx/3.63 Gy, and 51.6 Gy/12 fx/4.3 Gy, respectively with next level escalations contingent upon acceptable gastrointestinal (GI) toxicity. The primary endpoints were biochemical control and toxicity.

resultsA total of 347 patients were recruited by 5 institutions with 101, 111, and 135 patients treated on HPFX levels I, II, and III with median follow-ups of 100, 85.5, and 61.7 months, respectively (83.2 months combined). The National Comprehensive Cancer Network low- or intermediate-risk group distribution was 46% and 54%, respectively. Sixteen percent of patients, primarily intermediate risk, received 6 months of androgen deprivation therapy. The 8-year nadir + 2 actuarial biochemical control rates for HPFX levels I, II, and III were 91.1% ± 3.0%, 92.7% ± 2.7%, and 88.5% ± 4.6%, respectively (Kaplan-Meier log rank, 0.903). Among clinical covariates, only Gleason score reached near significance in multivariate analysis (P = .054). Twenty-six patients failed biochemically (crude incidence of 7.5%), and there were 5 cause-specific deaths. GI and genitourinary toxicities were acceptable and similar across the 3 HPFX levels. The combined actuarial cumulative incidence of grade 2+ GI and genitourinary toxicities at 7 years were 16.3% ± 2.1% and 22.1% ± 2.4%, respectively.

conclusionsHPFX employing fraction sizes extending into the 3.6 to 4.3 Gy/fraction range can be delivered with excellent oncologic outcomes. Such schedules, positioned between moderate and ultra-HPFX, may provide additional options for patients wishing to avoid prolonged treatment schedules associated with conventionally fractionated radiation therapy for prostate cancer.

Indexed as

Prostatic NeoplasmsAgedAged, 80 and overAndrogen AntagonistsHumansMaleMiddle AgedProspective StudiesProstate-Specific AntigenRadiation Dose HypofractionationUrogenital SystemAndrogen AntagonistsProstate-Specific Antigen

Identifiers

PMID32169590
PMCPMC7483248
OpenAlexW3010661922

What OpenQuestion holds

Textmetadata
LicenceTDM
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.