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Feasibility Study of Safety, Toxicity, and Compliance of Concomitant Chemoradiotherapy for HIV-Associated Locally-Advanced Cervical Cancer

Phase 2
18 Years
Not Enrolling
Cervical Cancer, Acquired Immunodeficiency Syndrome

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Trial Information

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
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

Inclusion Criteria


- Participants (who have been adequately clinically staged by standard clinical
guidelines) with primary, untreated, histologically confirmed, documented invasive
squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine
cervix, stages IB2, IIA, IIB, IIIA, IIIB, and IVA (Stage IIA tumors must be greater
than 4 cm)

- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or
chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and
confirmed by a licensed western blot or a second antibody test by a method other than
the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 ribonucleic
acid (RNA) viral load

- NOTE: the term "licensed" refers to a United States (U.S) Food and Drug
Administration (FDA)-approved kit or for sites located in countries other than
the United States, a kit that has been certified or licensed by an oversight
body within that country and validated internally

- WHO (World Health Organization) and CDC (Centers for Disease Control and
Prevention) guidelines mandate that confirmation of the initial test result must
use a test that is different from the one used for the initial assessment; a
reactive initial rapid test should be confirmed by either another type of rapid
assay or an E/CIA that is based on a different antigen preparation and/or
different test principle (e.g., indirect versus competitive), or a western blot
or a plasma HIV-1 RNA viral load

- No participants with carcinoma of the cervical stump


- Hemoglobin ≥ 10 g/dL (6.2 mmol/L)

- Platelet count ≥ 100,000/mm³ (100 x 10^9/L)

- Absolute neutrophil count (ANC) ≥ 1000/mm³ (1.0 x 10^9/L) (participants receiving
transfusion, erythropoietin, or myeloid growth factor support will be eligible for
this study)

- Creatinine clearance ≥ 60 mL/min (1.00 mL/s) calculated by the Cockcroft-Gault
equation for women

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper
limit of normal (ULN)

- Total bilirubin ≤ 2 times ULN unless related to antiretroviral use (e.g., atazanavir
and indinavir), then the direct bilirubin must be ≤ 2 times ULN

- Ability to understand and the willingness to provide informed consent to participate

- Karnofsky performance status of ≥ 60%

- Participants of childbearing potential, defined as a sexually mature woman who has
not undergone a hysterectomy or bilateral oophorectomy or has not been naturally
postmenopausal for at least 24 consecutive months (i.e., has had menses at any time
in the preceding 24 consecutive months), must have a negative urine or serum
pregnancy test within 3 weeks prior to enrollment and agree to use an effective form
of contraception (e.g., barrier contraception, highly effective hormonal

- Life expectancy of greater than 12 months

- No acute active (such as tuberculosis or malaria), serious, uncontrolled infection;
participants with a CD4 count < 50/mm³ (0.05 x 10^9/L) will be excluded if they have
had an opportunistic infection within the past 3 months, or if there is evidence of
resistance to antiretroviral therapy (i.e., HIV viral load ≥ 400 copies/mL despite
combination antiretroviral therapy for at least 4 months)

- No prior invasive malignancy other than LACC diagnosed within the past 24 months,
excluding anal intraepithelial neoplasia, non-melanoma skin carcinoma, or Kaposi
sarcoma that has not required systemic chemotherapy within the past 24 months

- No pregnancy or breast-feeding

- No medical or psychiatric illness that precludes ability to give informed consent or
is likely to interfere with the ability to comply with the protocol stipulations

- No participants with circumstances that will not permit completion of the study or
required follow-up; for instance, if travel to and from treatment site is an issue

- No participants with cardiovascular disease manifested as:

- History of myocardial infarction

- Unstable angina

- Currently taking medication for treatment of angina

- History of coronary artery bypass surgery

- New York Heart Association class 3 or 4 heart failure


- See Patient Characteristics

- All patients must be prescribed combination antiretroviral therapy with the goal of
virological suppression using an acceptable regimen that adheres to national
guidelines for treatment of HIV infection

- Non-suppressed, treatment-experienced patients, defined as patients with a viral
load > 400 copies/mL who have been on antiretroviral therapy for more than 4
months, can be enrolled if a genotype assay is performed and an acceptable
regimen is prescribed based on the genotyping results

- Patients who undergo emergency radiation therapy prior to enrollment may participate
at the investigator's discretion

- No participants who have undergone hysterectomy

- No concurrent intensity-modulated radiotherapy or interstitial brachytherapy

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment completion rate using the binomial proportion and its 95% confidence interval

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Mark H. Einstein, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


Kenya: Institutional Review Board

Study ID:




Start Date:

June 2013

Completion Date:

January 2016

Related Keywords:

  • Cervical Cancer
  • Acquired Immunodeficiency Syndrome
  • 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
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Uterine Cervical Neoplasms
  • Immunologic Deficiency Syndromes