Trial Outcomes & Findings for A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy (NCT NCT00590967)
NCT ID: NCT00590967
Last Updated: 2016-08-29
Results Overview
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
1 year post start of radiation therapy
Results posted on
2016-08-29
Participant Flow
The study opened to patient accrual on 05/01/2003 and closed to patient accrual on 04/24/2008.
Participant milestones
| Measure |
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET).
Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments)
Weekly cisplatin 40 mg/m\^2
|
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
25
|
|
Overall Study
COMPLETED
|
41
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET).
Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments)
Weekly cisplatin 40 mg/m\^2
|
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Ineligible
|
1
|
0
|
|
Overall Study
Poor performance status
|
0
|
1
|
|
Overall Study
Non-compliant
|
0
|
2
|
|
Overall Study
Did not sign consent form
|
0
|
1
|
|
Overall Study
Did not receive chemo per protocol
|
1
|
0
|
Baseline Characteristics
A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy
Baseline characteristics by cohort
| Measure |
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
n=41 Participants
Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin 40 mg/m\^2
|
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
n=20 Participants
Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
52 years
n=7 Participants
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
20 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post start of radiation therapy-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
n=41 Participants
Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
n=20 Participants
Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
|---|---|---|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Neutropenia
|
3 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Anorexia
|
1 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Diarrhea
|
1 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Hypomagnesemia
|
1 participants
|
0 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Leukopenia
|
2 participants
|
3 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Lymphopenia
|
1 participants
|
3 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Dyspnea
|
0 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Fatigue
|
0 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Hemoglobin
|
0 participants
|
2 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Hematocrit
|
0 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Hyperkalemia
|
0 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Hypoglycemia
|
0 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Hyponatremia
|
0 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Infection without neutropenia
|
0 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Platelets
|
0 participants
|
1 participants
|
|
Tolerance of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured the Number of Participants With by Grade 4 or Higher Toxicity
Renal failure
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 30 days after completion of radiation therapyOutcome measures
| Measure |
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
n=41 Participants
Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
n=20 Participants
Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
|---|---|---|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Anorexia
|
1 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Anxiety
|
1 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Diarrhea
|
5 participants
|
5 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Dyspnea
|
1 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Dysuria
|
1 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Fatigue
|
9 participants
|
4 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Granulocytes/bands
|
1 participants
|
2 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hemoglobin
|
2 participants
|
6 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hematocrit
|
1 participants
|
4 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Vaginal bleeding
|
1 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hyperglycemia
|
1 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hypermagnesemia
|
1 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hypertension
|
2 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hypocalcemia
|
3 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hypokalemia
|
5 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hyponatremia
|
3 participants
|
4 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hypomagnesemia
|
1 participants
|
5 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Infection with neutropenia
|
1 participants
|
2 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Infection (Urinalysis)
|
1 participants
|
3 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Leukopenia
|
10 participants
|
10 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Lymphopenia
|
35 participants
|
25 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Nausea
|
4 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Abdominal pain
|
3 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Pelvic pain
|
2 participants
|
2 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Pain - not otherwise specified (NOS)
|
4 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
packed red blood cell (PRBC) Transfusion
|
5 participants
|
11 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Platelets
|
2 participants
|
2 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Proteinuria
|
1 participants
|
0 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Skin
|
1 participants
|
2 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Vomiting
|
2 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Weight loss
|
2 participants
|
2 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Albumin
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Creatinine
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Vaginal mucosa erythematous
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Edema
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
erythrocyte sedimentation rate (ESR)
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hyperkalemia
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Hypoglycemia
|
0 participants
|
2 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
international normalized ratio (INR)
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Leucocyte esterase
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Prothrombin time (PT)
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
partial thromboplastin time (PTT)
|
0 participants
|
4 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Renal failure
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
aspartate aminotransferase (ALT)
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Yeast infection
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Absolute neutrophil count
|
6 participants
|
4 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Atrial fibrillation
|
0 participants
|
1 participants
|
|
Number of Participants With Acute Toxicity of IMRT Extended-field External Radiotherapy to Pelvis and Para-aortic Region, Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy (Grade 3 or Higher)
Confusion
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 1st PET scan after completion of treatment (approximately month 6)Outcome measures
| Measure |
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
n=41 Participants
Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
n=20 Participants
Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
|---|---|---|
|
Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status
Positive PET scan
|
6 participants
|
9 participants
|
|
Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status
Negative PET scan
|
27 participants
|
7 participants
|
|
Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status
Equivocal PET scan
|
6 participants
|
4 participants
|
|
Efficacy of IMRT Extended-field Radiation Combined With Intracavitary Irradiation, and Cisplatin Chemotherapy as Measured by PET Scan Disease Status
PET scan not performed
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 years after completion of radiation therapyPopulation: The data was not collected for this secondary outcome. Due to the the early termination of this study, only data for the primary outcomes were collected and analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
Serious events: 10 serious events
Other events: 41 other events
Deaths: 0 deaths
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
n=41 participants at risk
Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
n=20 participants at risk
Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
|---|---|---|
|
Vascular disorders
Hypertension
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
General disorders
Fever
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Nausea
|
14.6%
6/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Diarrhea
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
5/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Infections and infestations
Infection without neutropenia
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Leukopenia
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
General disorders
Fatigue
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Neutropenia (ANC)
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Lymphopenia
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Injury, poisoning and procedural complications
Skin pain
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
General disorders
Rigors/chills
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Urinary retention
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Infections and infestations
Polymicrobial sepsis
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
Other adverse events
| Measure |
Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)
n=41 participants at risk
Pelvic Lymph Nodes Only Positive on FDG PET.
IMRT External Beam radiation to the para-aortic region (45 Gy)
Pelvis intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)
n=20 participants at risk
Para-Aortic Lymph Nodes Positive on FDG PET
IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)
IMRT external beam pelvic radiation therapy as appropriate for stage
Intracavitary brachytherapy (6 HDR treatments)
Weekly cisplatin (40 mg/m\^2)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
22.0%
9/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
20.0%
4/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Absolute neutrophil count (ANC)
|
24.4%
10/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
55.0%
11/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Albumin
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Alkaline phosphatase
|
9.8%
4/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
30.0%
6/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Anorexia
|
39.0%
16/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
80.0%
16/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Psychiatric disorders
Anxiety
|
9.8%
4/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
25.0%
5/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
BUN
|
17.1%
7/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Bilirubin
|
14.6%
6/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
30.0%
6/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
CO2 (elevated)
|
14.6%
6/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Cardiac disorders
Cardiac dysrhythmias
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Cardiac disorders
Chest pain
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
General disorders
Chills
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Chloride
|
9.8%
4/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Psychiatric disorders
Confusion
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Constipation
|
17.1%
7/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
25.0%
5/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Creatinine
|
17.1%
7/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
45.0%
9/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Psychiatric disorders
Depression
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Skin and subcutaneous tissue disorders
Dermatologic (vaginal mucosa erythematous)
|
22.0%
9/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
50.0%
10/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Diarrhea
|
80.5%
33/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
100.0%
20/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Dysuria
|
22.0%
9/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
30.0%
6/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
General disorders
Edema
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
25.0%
5/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
General disorders
Fatigue
|
68.3%
28/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
95.0%
19/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
General disorders
Fever
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Granulocytes/Bands
|
9.8%
4/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
25.0%
5/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Blood and lymphatic system disorders
Hematologic - other (RBCs)
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Blood and lymphatic system disorders
Hematologic - other (hematocrit)
|
12.2%
5/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
35.0%
7/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Hematuria
|
19.5%
8/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
35.0%
7/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
80.5%
33/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
100.0%
20/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Hemorrhage (rectal bleeding)
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Reproductive system and breast disorders
Hemorrhage (vaginal bleeding)
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Vascular disorders
Hot flashes
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.2%
5/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
20.0%
4/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hyperproteinemia
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Vascular disorders
Hypertension
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.7%
13/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Hypobilirubinemia
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
40.0%
8/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
34.1%
14/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
60.0%
12/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
43.9%
18/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
29.3%
12/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
50.0%
10/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.8%
11/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
60.0%
12/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Vascular disorders
Hypotension
|
14.6%
6/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Infections and infestations
Infection (Respiratory)
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Infections and infestations
Infection (urinalysis)
|
19.5%
8/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
30.0%
6/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Infections and infestations
Infection with neutropenia
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
LDH
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Blood and lymphatic system disorders
Leucocyte esterase
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Leukopenia
|
65.9%
27/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
95.0%
19/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Lymphopenia
|
87.8%
36/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
100.0%
20/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Nausea
|
75.6%
31/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
100.0%
20/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Psychiatric disorders
Neuro-mood
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Nocturia
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Blood and lymphatic system disorders
PRBC Transfusion
|
12.2%
5/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
55.0%
11/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
PT
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
30.0%
6/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
PTT
|
12.2%
5/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
20.0%
4/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
General disorders
Pain NOS
|
17.1%
7/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Reproductive system and breast disorders
Pelvic pain
|
19.5%
8/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
30.0%
6/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Plasma Protein
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Platelets
|
41.5%
17/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
75.0%
15/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Proteinuria
|
14.6%
6/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
30.0%
6/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Rectal pain
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Renal failure
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
SGOT
|
12.2%
5/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
SGPT
|
7.3%
3/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
15.0%
3/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Cardiac disorders
Sinus bradycardia
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Skin and subcutaneous tissue disorders
Skin
|
53.7%
22/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
80.0%
16/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Skin and subcutaneous tissue disorders
Sun intolerance
|
4.9%
2/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
0.00%
0/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
26.8%
11/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
50.0%
10/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
1/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Vomiting
|
46.3%
19/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
60.0%
12/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
Weight loss
|
51.2%
21/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
50.0%
10/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Skin and subcutaneous tissue disorders
Dermatologic (local)
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Dyphagia/esophagitis
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Blood and lymphatic system disorders
ESR
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Gastrointestinal (heartburn)
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Investigations
INR
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Nervous system disorders
Memory loss
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
5.0%
1/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
|
Infections and infestations
Yeast infection
|
0.00%
0/41
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
10.0%
2/20
Serious adverse events are events that had serious adverse event reports filed with the institutional review board.
|
Additional Information
Perry Grigsby, M.D.
Washington University School of Medicine
Phone: 314-362-8502
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place