Trial Outcomes & Findings for Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer (NCT NCT01407107)
NCT ID: NCT01407107
Last Updated: 2021-01-14
Results Overview
DLT was defined as greater or equal to two instances of grade 3 toxicity, or a single event of grade 4-5 toxicity deemed probably or definitely related to the addition of transdermal neoadjuvant chemoradiation to the standard neoadjuvant chemoradiation
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Up to 4-6 weeks for each dosing cohort
Results posted on
2021-01-14
Participant Flow
Adult men and women otherwise eligible for medical care at Dallas VA Medical center were identified as they presented for consideration of standard therapy.
Participant milestones
| Measure |
Nitroglycerin 0.2mg/hr Cohort 1
Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
|
Nitroglycerin 0.4mg/hr Cohort 2
Nitroglycerin: 0.4mg/hr nitroglycerin transdermal patch daily
|
Nitroglycerin: 0.6mg/hr Cohort 3
Nitroglycerin: 0.6mg/hr nitroglycerin transdermal patch daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
3
|
|
Overall Study
COMPLETED
|
7
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=7 Participants
Dose escalation trial of Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
|
Cohort 2
n=3 Participants
nitroglycerin: 0.4 mg/hr nitroglycerin transdermal patch daily
|
Cohort 3
n=3 Participants
nitroglycerin: 0.6 mg/hr nitroglycerin transdermal patch daily
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants • After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
|
0 Participants
n=41 Participants • After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
|
0 Participants
n=35 Participants • After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
|
0 Participants
n=31 Participants • After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants • After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
|
3 Participants
n=41 Participants • After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
|
3 Participants
n=35 Participants • After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
|
13 Participants
n=31 Participants • After extensive effort to locate the raw data so that we can stratify by different cohorts, we were not able to get this data.
|
|
Region of Enrollment
United States
|
7 participants
n=39 Participants
|
3 participants
n=41 Participants
|
3 participants
n=35 Participants
|
13 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 4-6 weeks for each dosing cohortDLT was defined as greater or equal to two instances of grade 3 toxicity, or a single event of grade 4-5 toxicity deemed probably or definitely related to the addition of transdermal neoadjuvant chemoradiation to the standard neoadjuvant chemoradiation
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Dose escalation trial of Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
|
Cohort 2
n=3 Participants
nitroglycerin: 0.4 mg/hr nitroglycerin transdermal patch daily
|
Cohort 3
n=3 Participants
nitroglycerin: 0.6 mg/hr nitroglycerin transdermal patch daily
|
|---|---|---|---|
|
The Number of Participants Experiencing Dose Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time of surgery (~ 6-9 wks) following the completion of neoadjuvant therapypathological complete response (pCR) at time of surgery following the completion of neoadjuvant therapy. This will be compared to the institutional historical pCR rate. Pathologic complete response indicates a complete absence of cancer at the time of surgical resection.
Outcome measures
| Measure |
Cohort 1
n=7 Participants
Dose escalation trial of Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
|
Cohort 2
n=3 Participants
nitroglycerin: 0.4 mg/hr nitroglycerin transdermal patch daily
|
Cohort 3
n=3 Participants
nitroglycerin: 0.6 mg/hr nitroglycerin transdermal patch daily
|
|---|---|---|---|
|
Number of Participants With a Pathological Complete Response (pCR)
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=7 participants at risk
Dose escalation trial of Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
|
Cohort 2
n=3 participants at risk
nitroglycerin: 0.4 mg/hr nitroglycerin transdermal patch daily
|
Cohort 3
n=3 participants at risk
nitroglycerin: 0.6 mg/hr nitroglycerin transdermal patch daily
|
|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
Other adverse events
| Measure |
Cohort 1
n=7 participants at risk
Dose escalation trial of Nitroglycerin: 0.2mg/hr nitroglycerin transdermal patch daily
|
Cohort 2
n=3 participants at risk
nitroglycerin: 0.4 mg/hr nitroglycerin transdermal patch daily
|
Cohort 3
n=3 participants at risk
nitroglycerin: 0.6 mg/hr nitroglycerin transdermal patch daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Vascular disorders
Grade 3 Headache
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
100.0%
3/3 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Abdominal Pain
|
42.9%
3/7 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
3/7 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
28.6%
2/7 • Number of events 2 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
28.6%
2/7 • Number of events 2 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 7 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Flatulence
|
28.6%
2/7 • Number of events 2 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Hepatobiliary disorders
GGT Elevation
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Infections and infestations
Hand/Foot Syndrome
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Endocrine disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Endocrine disorders
Hypoalbuminemia
|
14.3%
1/7 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypokalmia
|
42.9%
3/7 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Hypotension
|
28.6%
2/7 • Number of events 2 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
42.9%
3/7 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Nausea/Vomitting
|
42.9%
3/7 • Number of events 8 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Cardiac disorders
Orthostatic Hypotension
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
General disorders
Photosensitivity
|
42.9%
3/7 • Number of events 3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
General disorders
Radiation Proctitis
|
42.9%
3/7 • Number of events 7 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
2/7 • Number of events 2 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Urinary Retention
|
28.6%
2/7 • Number of events 2 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Urinary Tract Infection
|
14.3%
1/7 • Number of events 1 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
0.00%
0/3 • From the first clinic visit to 4-12 weeks after surgery or until resolution of all acute side effects from radiation had occurred, approximately 5 years
investigator assessment, regular laboratory testing
|
Additional Information
Dr. Jonathan Dowell
University of Texas Southwestern Medical Center
Phone: 214-648-7097
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place