Evidence map›Paper›PMID 25670539›Full record

Trial reportInternational journal of radiation oncology, biology, physics2015

Radiotherapy quality assurance report from children's oncology group AHOD0031.

Kavita V Dharmarajan, Debra L Friedman, T J FitzGerald, Kathleen M McCarten, Louis S Constine, Lu Chen, Sandy K Kessel, Matt Iandoli, Fran Laurie, Cindy L Schwartz and 1 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. A dedicated cloud system for real-time upfront quality assurance in pediatric radiation therapy.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2019
    Trial
  2. Review
  3. Whole Lung Irradiation in Rhabdomyosarcoma With Lung Metastases: A Report From the Soft Tissue Sarcoma Committee of the Children's Oncology Group.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Article
  4. Review
  5. Review
  6. Quality assurance in radiation oncology.Pediatric blood & cancer · 2021
    Review
  7. Review
  8. Article
  9. Review
  10. Imaging and Data Acquisition in Clinical Trials for Radiation Therapy.International journal of radiation oncology, biology, physics · 2016
    Review
  11. Article
  12. 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

11 authors.

Kavita V DharmarajanMount Sinai Medical Center, New York, New York.
Debra L FriedmanVanderbilt University, Nashville, Tennessee.
T J FitzGeraldQuality Assurance Review Center, Lincoln, Rhode Island.
Kathleen M McCartenRhode Island Hospital/Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Louis S ConstineUniversity of Rochester Medical Center, Rochester, New York.
Lu ChenChildren's Oncology Group, Arcadia, California.
Sandy K KesselQuality Assurance Review Center, Lincoln, Rhode Island.
Matt IandoliQuality Assurance Review Center, Lincoln, Rhode Island.
Fran LaurieQuality Assurance Review Center, Lincoln, Rhode Island.
Cindy L SchwartzMD Anderson Cancer Center, Houston, Texas.
Suzanne L WoldenMemorial Sloan-Kettering Cancer Center, New York, New York. Electronic address: woldens@mskcc.org.

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI DEVIDAS, MEENAKSHI · 2003 to 2013
$67.5M
QUALITY ASSURANCE REVIEW CENTER (QARC)U10CA029511 · NCI · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI FITZGERALD, THOMAS J. · 1985 to 2013
$23.4M
NCI NIH HHS U10 CA029511NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

purposeA phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy (IFRT) and imaging records by a centralized review center to maximize protocol compliance. We report the impact of centralized radiation therapy review on protocol compliance. METHODS AND MATERIALS: Review of simulation films, port films, and dosimetry records was required before and after treatment. Records were reviewed by study-affiliated or review center-affiliated radiation oncologists. A deviation of 6% to 10% from protocol-specified dose was scored as "minor"; a deviation of >10% was "major." A volume deviation was scored as "minor" if margins were less than specified or "major" if fields transected disease-bearing areas. Interventional review and final compliance review scores were assigned to each radiation therapy case and compared.

resultsOf 1712 patients enrolled, 1173 underwent IFRT at 256 institutions in 7 countries. An interventional review was performed in 88% of patients and a final review in 98%. Overall, minor and major deviations were found in 12% and 6% of patients, respectively. Among the cases for which ≥1 pre-IFRT modification was requested by the Quality Assurance Review Center and subsequently made by the treating institution, 100% were made compliant on final review. By contrast, among the cases for which ≥1 modification was requested but not made by the treating institution, 10% were deemed compliant on final review.

conclusionsIn a large trial with complex treatment pathways and heterogeneous radiation therapy fields, central review was performed in a large percentage of cases before IFRT and identified frequent potential deviations in a timely manner. When suggested modifications were performed by the institutions, deviations were almost eliminated.

Indexed as

Guideline AdherenceQuality Assurance, Health CareAdolescentAntineoplastic Combined Chemotherapy ProtocolsBleomycinChildChild, PreschoolCyclophosphamideDoxorubicinEtoposideHodgkin DiseaseHumansInfantInfant, NewbornPrednisoneRadiographyBleomycinCyclophosphamideDoxorubicinEtoposidePrednisoneVincristine

Identifiers

PMID25670539
PMCPMC5240783

What OpenQuestion holds

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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.