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Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01590017
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The Emmes Company
University of Arkansas
Montefiore Medical Center
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Cancer
Acquired Immunodeficiency Syndrome
Interventions Drug: cisplatin
Radiation: external beam radiation therapy
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cistplatin and Radiation Therapy
Hide Arm/Group Description

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).

cisplatin

external beam radiation therapy

Period Title: Overall Study
Started 41
Completed 37
Not Completed 4
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Lack of Efficacy             1
Physician Decision             1
Arm/Group Title Cistplatin and Radiation Therapy
Hide Arm/Group Description

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).

cisplatin

external beam radiation therapy

Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
Patients who enrolled in the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
44.2  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
41
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
41
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants
South Africa 15
Zimbabwe 26
1.Primary Outcome
Title Treatment Completion Rate Using the Binomial Proportion and Its 95% Confidence Interval
Hide Description Number of participants who completed therapy
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cistplatin and Radiation Therapy
Hide Arm/Group Description:

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).

cisplatin

external beam radiation therapy

Overall Number of Participants Analyzed 41
Measure Type: Count of Participants
Unit of Measure: Participants
37
  90.2%
2.Primary Outcome
Title Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria (CTC) Version 4.0 Will be Tabulated
Hide Description Number of patients who experienced one or more adverse events
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cistplatin and Radiation Therapy
Hide Arm/Group Description:

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).

cisplatin

external beam radiation therapy

Overall Number of Participants Analyzed 41
Measure Type: Count of Participants
Unit of Measure: Participants
39
  95.1%
Time Frame One year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cistplatin and Radiation Therapy
Hide Arm/Group Description

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).

cisplatin

external beam radiation therapy

All-Cause Mortality
Cistplatin and Radiation Therapy
Affected / at Risk (%)
Total   7/41 (17.07%) 
Hide Serious Adverse Events
Cistplatin and Radiation Therapy
Affected / at Risk (%)
Total   10/41 (24.39%) 
Blood and lymphatic system disorders   
anemia * 1  1/41 (2.44%) 
Gastrointestinal disorders   
Vomiting * 1  2/41 (4.88%) 
Diarrhea * 1  1/41 (2.44%) 
General disorders   
Death NOS * 1  1/41 (2.44%) 
Flu-like symptoms * 1  1/41 (2.44%) 
Investigations   
Neutrophil count decreased * 1  1/41 (2.44%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastatic Cancer of the uterine cervix * 1  5/41 (12.20%) 
Renal and urinary disorders   
Chronic kidney disease * 1  1/41 (2.44%) 
Vascular disorders   
Thromboembolic event * 1  2/41 (4.88%) 
1
Term from vocabulary, MedDRA (10.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cistplatin and Radiation Therapy
Affected / at Risk (%)
Total   39/41 (95.12%) 
Blood and lymphatic system disorders   
Anemia * 1  13/41 (31.71%) 
Gastrointestinal disorders   
Constipation * 1  4/41 (9.76%) 
Diarrhea * 1  5/41 (12.20%) 
Hemorrhoids * 1  4/41 (9.76%) 
Vomiting * 1  3/41 (7.32%) 
Infections and infestations   
Infections * 1  4/41 (9.76%) 
Urinary tract infection * 1  3/41 (7.32%) 
Investigations   
Lymphocyte decreased * 1  15/41 (36.59%) 
Neutrophil count decrease * 1  36/41 (87.80%) 
Platelet count decreased * 1  17/41 (41.46%) 
White blood cell decreased * 1  15/41 (36.59%) 
Weight loss * 1  8/41 (19.51%) 
Metabolism and nutrition disorders   
Hypokalemia * 1  3/41 (7.32%) 
Hypomagnesia * 1  7/41 (17.07%) 
Hyponatremia * 1  11/41 (26.83%) 
Musculoskeletal and connective tissue disorders   
Pain * 1  3/41 (7.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastatic cervix cancer * 1  3/41 (7.32%) 
Renal and urinary disorders   
Chronic kidney disease * 1  3/41 (7.32%) 
Urinary tract pain * 1  6/41 (14.63%) 
Reproductive system and breast disorders   
Vaginal discharge * 1  7/41 (17.07%) 
Vaginal hemorrhage * 1  3/41 (7.32%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/41 (7.32%) 
Skin and subcutaneous tissue disorders   
Desquamation of the perineum * 1  3/41 (7.32%) 
Vascular disorders   
Hypertension * 1  9/41 (21.95%) 
1
Term from vocabulary, MedDRA (10.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeannette Lee, PhD.
Organization: AMC Statistical Center
Phone: 501-526-6712
EMail: jylee@uams.edu
Layout table for additonal information
Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT01590017    
Other Study ID Numbers: AMC-081
CDR0000732629 ( Other Identifier: NCI )
UM1CA121947 ( U.S. NIH Grant/Contract )
First Submitted: May 1, 2012
First Posted: May 2, 2012
Results First Submitted: July 18, 2019
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019