Quality Assurance in Clinical Trials Requiring Radiation Therapy in Sub-Saharan Africa
- PMID: 36493958
- PMCID: PMC10360026
- DOI: 10.1016/j.ijrobp.2022.11.042
Quality Assurance in Clinical Trials Requiring Radiation Therapy in Sub-Saharan Africa
Abstract
Purpose: Given 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/m2). IROC reviewed EBRT and brachytherapy quality assurance records after treatment.
Results: All 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.
Conclusions: Major 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.
Copyright © 2022 Elsevier Inc. All rights reserved.
Conflict of interest statement
Dr Lin receives grant support from the NCI. The University of Texas, MD Anderson Cancer Center has received grant funding from investigator initiated clinical trials for which Dr Lin has been the overall PI within the past 36 months including from Astrazeneca and Pfizer. Dr Palefsky reports institutional grant support from Merck and Bausch Health as well as honoraria for lectures, presentations, speakers bureaus from Merck and Theratechnologies. Dr Krown was the AMC Vice-Chair for International Activities during the development and conduct of AMC-081 and receivde direct payments for salary support from the AIDS Malignancy Consortium grant, through the Emmes Corp and the University of California Los Angeles. Dr. Einstein has advised or participated in educational speaking activities but does not receive an honorarium from any companies. In specific cases, his employer has received payment for his time spent for these activities from Merck, Douglas Pharmaceuticals Ltd, and PDS Biotechnologies. If travel required for meetings with industry, the company pays for Dr. Einstein’s travel expenses. Rutgers has received grant funding for research-related costs of clinical trials that he has been the overall or local PI within the past 12 months from Inovio, Merck Sharp and Dohme Corp., Iovance, Papivax and VBL Therapeutics.
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References
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- Global strategy to accelerate the elimination of cervical cancer as a public health problem. World Health Organization, 2020.
