Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer
Condition: Cervical Cancer; Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Uterine Cervical Neoplasms; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  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.

      Secondary

        -  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.
    

Intervention name(s): cisplatin; external beam radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer; cervical adenocarcinoma; cervical adenosquamous cell carcinoma; cervical squamous cell carcinoma; HIV infection