1. Quality Assurance in Clinical Trials Requiring Radiation Therapy in Sub-Saharan Africa
- Author
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Lin, Lilie L, Ndlovu, Ntokozo, Lowenstein, Jessica, Wirth, Meg, Lee, Jeannette, Stier, Elizabeth A, Garg, Madhur, Kotzen, Jeffrey, Kadzatsa, Webster, Palefsky, Joel, Krown, Susan E, and Einstein, Mark H
- Subjects
Medical and Biological Physics ,Biomedical and Clinical Sciences ,Clinical Sciences ,Physical Sciences ,Oncology and Carcinogenesis ,Cancer ,Clinical Research ,Clinical Trials and Supportive Activities ,HIV/AIDS ,Female ,Humans ,Cisplatin ,Acquired Immunodeficiency Syndrome ,Brachytherapy ,Radiotherapy Dosage ,Africa South of the Sahara ,Neoplasms ,Uterine Cervical Neoplasms ,Neoplasm Staging ,Multicenter Studies as Topic ,Other Physical Sciences ,Oncology & Carcinogenesis ,Oncology and carcinogenesis ,Theoretical and computational chemistry ,Medical and biological physics - 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 materialsWomen 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.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.
- Published
- 2023