Evidence map›Paper›PMID 36493958›Full record

ReviewInternational journal of radiation oncology, biology, physics2023

Quality Assurance in Clinical Trials Requiring Radiation Therapy in Sub-Saharan Africa.

Lilie L Lin, Ntokozo Ndlovu, Jessica Lowenstein, Meg Wirth, Jeannette Lee, Elizabeth A Stier, Madhur Garg, Jeffrey Kotzen, Webster Kadzatsa, Joel Palefsky and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in International journal of radiation oncology, biology, physics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

12 authors.

Lilie L LinDepartment of Radiation Oncology, University of Texas, MD Anderson Cancer Center, Houston, Texas. Electronic address: LLLin@mdanderson.org.
Ntokozo NdlovuCollege of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
Jessica LowensteinDepartment of Radiation Physics and the Imaging and Radiation Oncology Core, University of Texas, MD Anderson Cancer Center, Houston, Texas.
Meg WirthEmmes Company, Rockville, Maryland.
Jeannette LeeDepartment of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
Elizabeth A StierDepartment of Obstetrics and Gynecology, Boston University School of Medicine, Boston, Massachusetts.
Madhur GargDepartment of Radiation Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Yeshiva University, New York, New York.
Jeffrey KotzenDepartment of Radiation Oncology, University of the Witwatersrand, Johannesburg, South Africa.
Webster KadzatsaDepartment of Radiotherapy and Oncology, College of Health Science, University of Zimbabwe, Harare, Zimbabwe.
Joel PalefskyDepartment of Medicine, University of California, San Francisco, California.
Susan E KrownMemorial Sloan Kettering Cancer Center, New York, New York.
Mark H EinsteinDepartment of Obstetrics, Gynecology, and Women's Health, Rutgers New Jersey Medical School, Newark, New Jersey.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Elisa de Stanchina · 1985 to 2026
$347.4M
Consortium for Advancing Management and Prevention of Cancer in People with HIVUM1CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Joseph A. Sparano · 2015 to 2026
$253.7M
University of Southern CaliforniaU01CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI MITSUYASU, RONALD T. · 2006 to 2014
$54.7M
WOMEN'S HEALTH AGENDAU01AI027660 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CURRIER, JUDITH S. · 1988 to 2006
$11.8M
NCI NIH HHS P30 CA008748NCI NIH HHS U01 CA121947NCI NIH HHS UM1 CA121947NIAID NIH HHS U01 AI027660
6 · The paper itself

Abstract

purposeGiven the increasing availability of radiation therapy in sub-Saharan Africa, clinical trials that include radiation therapy are likely to grow. Ensuring appropriate delivery of radiation therapy through rigorous quality assurance is an important component of clinical trial execution. We reviewed the process for credentialing radiation therapy sites and radiation therapy quality assurance through the Imaging and Radiation Oncology Core (IROC) Houston Quality Assurance Center for AIDS Malignancy Consortium (AMC)-081, a multicenter study of cisplatin and radiation therapy for women with locally advanced cervical cancer living with HIV, conducted by the AIDS Malignancy Consortium at 2 sites in South Africa and Zimbabwe. METHODS AND MATERIALS: Women living with HIV with newly diagnosed stage IB2, IIA (>4 cm), IIB-IVA cervical carcinoma (per the 2009 International Federation of Gynecology and Obstetrics [FIGO] staging classifications) were enrolled in AMC-081. They received 3-dimensional conformal external beam radiation therapy (EBRT) to the pelvis (41.4-45 Gy) using a linear accelerator, high-dose-rate brachytherapy (6-9 Gy to point A with each fraction and up to 4 fractions), and concurrent weekly cisplatin (40 mg/m

resultsAll of the 38 women enrolled in AMC-081 received ±5% of the protocol-specified prescribed dose of EBRT. Geometry of brachytherapy applicator placement was scored as per protocol in all implants. Doses to points A and B, International Commission on Radiation Units and Measurements (ICRU) bladder, or ICRU rectum required correction by IROC in >50% of the implants. In the final evaluation, 58% of participants (n = 22) were treated per protocol, 40% (n = 15) had minor protocol deviations, and 3% (n = 1) had major protocol deviations. No records were received within 60 days of treatment completion as requested in the protocol.

conclusionsMajor radiation therapy deviations were low, but timely submission of radiation therapy data did not occur. Future studies, especially those that include specialized radiation therapy techniques such as stereotactic or intensity-modulated radiation therapy, will require pathways to ensure timely and adequate quality assurance.

Indexed as

Acquired Immunodeficiency SyndromeBrachytherapyNeoplasmsUterine Cervical NeoplasmsAfrica South of the SaharaCisplatinFemaleHumansMulticenter Studies as TopicNeoplasm StagingRadiotherapy DosageCisplatin

Identifiers

PMID36493958
PMCPMC10360026

What OpenQuestion holds

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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.