Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01590017|
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Acquired Immunodeficiency Syndrome||Drug: cisplatin Radiation: external beam radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Safety, Toxicity, and Compliance of Concomitant Chemoradiotherapy for HIV-Associated Locally-Advanced Cervical Cancer|
|Actual Study Start Date :||April 1, 2014|
|Actual Primary Completion Date :||April 20, 2017|
|Actual Study Completion Date :||April 20, 2017|
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).
Radiation: external beam radiation therapy
- Treatment Completion Rate Using the Binomial Proportion and Its 95% Confidence Interval [ Time Frame: 8 weeks ]Number of participants who completed therapy
- Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria (CTC) Version 4.0 Will be Tabulated [ Time Frame: 12 months ]Number of patients who experienced one or more adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590017
|Clinical HIV Research Unit, a Division of the Wits Health Consortium (Pty) Ltd|
|Johannesburg, South Africa, 2092|
|University of Zimbabwe Clinical Research Centre / Parirenyatwa Hospital|
|Principal Investigator:||Mark H. Einstein, MD, MS||Albert Einstein College of Medicine|