Feasibility Study of Safety, Toxicity, and Compliance of Concomitant Chemoradiotherapy for HIV-Associated Locally-Advanced Cervical Cancer
- To determine if it is feasible to administer a regimen of cisplatin/radiotherapy in
HIV-infected women with locally advanced cervical cancer (LACC) on antiretroviral
- To evaluate the safety and tolerability of concomitant chemoradiotherapy with cisplatin
in HIV-infected women with LACC who are also receiving concomitant ART.
- To determine the 1-year progression-free survival (PFS) of HIV-infected women with LACC
Stage IB, II, III, or IVA who receive weekly cisplatin concomitant with radiotherapy
and ART. (Exploratory)
- To describe the quality of life (QOL) of enrolled participants via assessments before,
immediately after, and at 3 and 9 months after completion of therapy, using QOL metrics
that have been validated in similar populations. (Exploratory)
- To describe the effects of treatment on participants' CD4 counts, HIV viral load, and
concurrent AIDS-defining conditions. (Exploratory)
- To describe cervical cancer recurrence patterns in HIV-infected participants with LACC
defined as loco-regional and/or distant recurrences. (Exploratory)
- To determine 1-year overall survival and causes of death (i.e., cancer-related,
HIV-related, or other). (Exploratory)
- To collect serum, cytology, and tissue for future studies specific to cervical and anal
- To evaluate the effects of weekly cisplatin concomitant with radiotherapy on adherence
to ART. (Exploratory)
OUTLINE: This is a multicenter study.
Participants receive cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36 (6
weeks total). Participants also undergo whole pelvic radiotherapy (WPRT) 5 days a week for 5
weeks followed by intracavitary brachytherapy.
Participants complete the European Organization for Research and Treatment of Cancer (EORTC)
Quality of Life Questionnaire (QLQ)-30 and the Cervical Cancer Module (QLQ-CX24) at baseline
and periodically during study treatment.
After completion of study treatment, participants are followed up every 3 months for 12
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment completion rate using the binomial proportion and its 95% confidence interval
Mark H. Einstein, MD, MS
Albert Einstein College of Medicine of Yeshiva University
Kenya: Institutional Review Board