Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving cisplatin together with radiation therapy may be an effective treatment for cervical cancer.
PURPOSE: This trial studies how well cisplatin and radiation therapy work in treating participants with HIV-associated locally advanced cervical cancer.
Acquired Immunodeficiency Syndrome
Radiation: external beam radiation therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study of Safety, Toxicity, and Compliance of Concomitant Chemoradiotherapy for HIV-Associated Locally-Advanced Cervical Cancer|
- Treatment completion rate using the binomial proportion and its 95% confidence interval [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Adverse events as graded by the National Cancer Institute Common Terminology Criteria (CTC) version 4.0 will be tabulated [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Cistplatin and Radiation Therapy
Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).
|Drug: cisplatin Radiation: external beam radiation therapy|
- 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 therapy (ART).
- 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 disease. (Exploratory)
- 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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590017
|Clinical HIV Research Unit, a Division of the Wits Health Consortium (Pty) Ltd||Recruiting|
|Johannesburg, South Africa, 2092|
|Contact: J A Kotzen, MD +27 11 481 2129 email@example.com|
|Principal Investigator: J A Kotzen, MD|
|Principal Investigator:||Mark H. Einstein, MD, MS||Albert Einstein College of Medicine of Yeshiva University|