Trial Outcomes & Findings for Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer (NCT NCT01590017)
NCT ID: NCT01590017
Last Updated: 2022-07-27
Results Overview
Number of participants who completed therapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-07-27
Participant Flow
Participant milestones
| Measure |
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).
cisplatin
external beam radiation therapy
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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).
cisplatin
external beam radiation therapy
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer
Baseline characteristics by cohort
| Measure |
Cistplatin and Radiation Therapy
n=41 Participants
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
|
|---|---|
|
Age, Continuous
|
44.2 years
STANDARD_DEVIATION 5.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
South Africa
|
15 participants
n=93 Participants
|
|
Region of Enrollment
Zimbabwe
|
26 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8 weeksNumber of participants who completed therapy
Outcome measures
| Measure |
Cistplatin and Radiation Therapy
n=41 Participants
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
|
|---|---|
|
Treatment Completion Rate
|
37 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of patients who experienced one or more adverse events
Outcome measures
| Measure |
Cistplatin and Radiation Therapy
n=41 Participants
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
|
|---|---|
|
Patients With Adverse Events
|
39 Participants
|
Adverse Events
Cistplatin and Radiation Therapy
Serious events: 10 serious events
Other events: 39 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cistplatin and Radiation Therapy
n=41 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
4.9%
2/41 • One year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Cancer of the uterine cervix
|
12.2%
5/41 • One year
|
|
Vascular disorders
Thromboembolic event
|
4.9%
2/41 • One year
|
|
Blood and lymphatic system disorders
anemia
|
2.4%
1/41 • One year
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/41 • One year
|
|
General disorders
Death NOS
|
2.4%
1/41 • One year
|
|
General disorders
Flu-like symptoms
|
2.4%
1/41 • One year
|
|
Investigations
Neutrophil count decreased
|
2.4%
1/41 • One year
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.4%
1/41 • One year
|
Other adverse events
| Measure |
Cistplatin and Radiation Therapy
n=41 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
31.7%
13/41 • One year
|
|
Gastrointestinal disorders
Constipation
|
9.8%
4/41 • One year
|
|
Gastrointestinal disorders
Diarrhea
|
12.2%
5/41 • One year
|
|
Gastrointestinal disorders
Hemorrhoids
|
9.8%
4/41 • One year
|
|
Gastrointestinal disorders
Vomiting
|
7.3%
3/41 • One year
|
|
Infections and infestations
Infections
|
9.8%
4/41 • One year
|
|
Infections and infestations
Urinary tract infection
|
7.3%
3/41 • One year
|
|
Investigations
Lymphocyte decreased
|
36.6%
15/41 • One year
|
|
Investigations
Neutrophil count decrease
|
87.8%
36/41 • One year
|
|
Investigations
Platelet count decreased
|
41.5%
17/41 • One year
|
|
Investigations
White blood cell decreased
|
36.6%
15/41 • One year
|
|
Investigations
Weight loss
|
19.5%
8/41 • One year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.3%
3/41 • One year
|
|
Metabolism and nutrition disorders
Hypomagnesia
|
17.1%
7/41 • One year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.8%
11/41 • One year
|
|
Musculoskeletal and connective tissue disorders
Pain
|
7.3%
3/41 • One year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic cervix cancer
|
7.3%
3/41 • One year
|
|
Renal and urinary disorders
Chronic kidney disease
|
7.3%
3/41 • One year
|
|
Renal and urinary disorders
Urinary tract pain
|
14.6%
6/41 • One year
|
|
Reproductive system and breast disorders
Vaginal discharge
|
17.1%
7/41 • One year
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
7.3%
3/41 • One year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
3/41 • One year
|
|
Skin and subcutaneous tissue disorders
Desquamation of the perineum
|
7.3%
3/41 • One year
|
|
Vascular disorders
Hypertension
|
22.0%
9/41 • One year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place