Evidence map›Paper›PMID 35198833›Full record

ArticleAdvances in radiation oncology

An International Consensus on the Design of Prospective Clinical-Translational Trials in Spatially Fractionated Radiation Therapy.

Nina A Mayr, James W Snider, William F Regine, Majid Mohiuddin, Daniel S Hippe, José Peñagarícano, Mohammed Mohiuddin, Mahesh R Kudrimoti, Hualin Zhang, Charles L Limoli and 2 more

Open access · goldAbstract read
In one paragraph

Article in Advances in radiation oncology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
7.4field-weighted citation impact, top 2% 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

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

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  6. Feasibility, safety, and clinical outcomes analysis of dense-lattice radiation therapy in palliative care for cancer patients´.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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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

12 authors at 11 institutions in 1 country.

Nina A MayrDepartment of Radiation Oncology, University of Washington School of Medicine, Seattle, Washington.
James W SniderDepartment of Radiation Oncology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama.
William F RegineDepartment of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland.
Majid MohiuddinRadiation Oncology Consultants and Northwestern Proton Center, Warrenville, Illinois.
Daniel S HippeClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
José PeñagarícanoMoffitt Cancer Center, Tampa, Florida.
Mohammed MohiuddinRadiation Oncology, Scottsdale, Arizona.
Mahesh R KudrimotiDepartment of Radiation Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.
Hualin ZhangDepartment of Radiation Oncology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Charles L LimoliDepartment of Radiation Oncology, University of California School of Medicine, Irvine, Irvine, California.
Quynh-Thu LeDepartment of Radiation Oncology, Stanford University, Stanford, California.
Charles B SimoneDepartment of Radiation Oncology, New York Proton Center, New York, New York.
Pinnacle Oncology Hematology · USFred Hutch Cancer Center · USMoffitt Cancer Center · USNew York Proton Center · USNorthwestern University · USStanford University · USUniversity of Alabama at Birmingham · USUniversity of California, Irvine · USUniversity of Kentucky · USUniversity of Maryland, Baltimore · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSpatially fractionated radiation therapy (SFRT), which delivers highly nonuniform dose distributions instead of conventionally practiced homogeneous tumor dose, has shown high rates of clinical response with minimal toxicities in large-volume primary or metastatic malignancies. However, prospective multi-institutional clinical trials in SFRT are lacking, and SFRT techniques and dose parameters remain variable. Agreement on dose prescription, technical administration, and clinical and translational design parameters for SFRT trials is essential to enable broad participation and successful accrual to rigorously test the SFRT approach. We aimed to develop a consensus for the design of multi-institutional clinical trials in SFRT, tailored to specific primary tumor sites, to help facilitate development and enhance the feasibility of such trials. METHODS AND MATERIALS: Primary tumor sites with sufficient pilot experience in SFRT were identified, and fundamental trial design questions were determined. For each tumor site, a comprehensive consensus effort was established through disease-specific expert panels. Clinical trial design criteria included eligibility, SFRT technology and technique, dose and fractionation, target- and normal-tissue dose parameters, systemic therapies, clinical trial endpoints, and translational science considerations. Iterative appropriateness rank voting, expert panel consensus reviews and discussions, and public comment posting were used for consensus development.

resultsClinical trial criteria were developed for head and neck cancer and soft-tissue sarcoma. Final consensus among the 22 trial design categories each (a total of 163 criteria) was high to moderate overall. Uniform patient cohorts of advanced bulky disease, standardization of SFRT technologies and dosimetry and physics parameters, and collection of translational correlates were considered essential to trial design. Final guideline recommendations and the degree of agreement are presented and discussed.

conclusionsThis consensus provides design guidelines for the development of prospective multi-institutional clinical trials testing SFRT in advanced head and neck cancer and soft-tissue sarcoma through in-advance harmonization of the fundamental clinical trial design among SFRT experts, potential investigators, and the SFRT community.

Identifiers

PMID35198833
PMCPMC8843999
OpenAlexW4200096471

What OpenQuestion holds

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LicenceCC BY
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.