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Trial record 1 of 1464 for:    prostate cancer AND radiation
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Intensity Modulated Radiation Therapy for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00214422
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : March 1, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Camphausen, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Radiation: Radiation
Enrollment 19
Recruitment Details  
Pre-assignment Details 6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes
Hide Arm/Group Description

5040 Gray (cGy) to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5400cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5900cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

Period Title: Overall Study
Started 12 3 4
Completed 7 2 3
Not Completed 5 1 1
Reason Not Completed
Physician Decision             2             0             0
Developed esophageal ca             1             0             0
Pt taken off study             1             1             0
Disease progression on study             1             0             0
Unable to make a radiation treatment             0             0             1
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes Total
Hide Arm/Group Description

5040 Gray (cGy) to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5400cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5900cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

Total of all reporting groups
Overall Number of Baseline Participants 12 3 4 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 4 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  58.3%
2
  66.7%
0
   0.0%
9
  47.4%
>=65 years
5
  41.7%
1
  33.3%
4
 100.0%
10
  52.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 3 participants 4 participants 19 participants
64.14  (7.41) 59.37  (20.36) 67.68  (2.78) 64.13  (9.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 4 participants 19 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
12
 100.0%
3
 100.0%
4
 100.0%
19
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 4 participants 19 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
12
 100.0%
3
 100.0%
4
 100.0%
19
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 4 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   8.3%
0
   0.0%
0
   0.0%
1
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
2
  66.7%
0
   0.0%
4
  21.1%
White
9
  75.0%
1
  33.3%
4
 100.0%
14
  73.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 3 participants 4 participants 19 participants
12
 100.0%
3
 100.0%
4
 100.0%
19
 100.0%
Median Prostatic Specific Antigen (PSA) at Diagnosis   [1] 
Median (Full Range)
Unit of measure:  Ng/ml
Number Analyzed 12 participants 3 participants 4 participants 19 participants
16.65
(5.5 to 103)
33.4
(5.7 to 42.9)
8.95
(4.75 to 27.3)
19.67
(4.75 to 103)
[1]
Measure Description: Normal PSA is less than 2.5 ng/ml.
Median Gleason Score at Diagnosis   [1] 
Median (Full Range)
Unit of measure:  Scores on a scale
Number Analyzed 12 participants 3 participants 4 participants 19 participants
8
(7 to 9)
7
(6 to 9)
8
(7 to 8)
7.6
(6 to 9)
[1]
Measure Description: Gleason grading scale helps to evaluate the severity of prostate cancer. A score >8 is a low-grade cancer (less aggressive). A score <8 is a high grade cancer (more aggressive, poor prognosis).
1.Primary Outcome
Title Number of Participants With Any Grade 2 Toxicity Using Intensity Modulated Radiation Therapy (IMRT) to Treat the At-risk Lymph Nodes in Prostate Cancer ( up to First 10 Patients)
Hide Description Radiation side effects were assessed by the Radiation Oncology Group (RTOG) Acute/Late Toxicity Grading Gastrointestinal and Genitourinary criteria. Acute Grade 0 - no symptoms, Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life threatening, and Grade 5 is death directly related to radiation side effects. Late toxicity is defined as occurring after 90 days.
Time Frame At one week, one month, 2 months, 3 months, 6 months, 9 months, 1 year, 18 months, 2 years, 30 months, and 3 years after radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
6 participants in Arm 1 participated in a feasibility phase prior to the dose escalation phase of the study.
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes
Hide Arm/Group Description:

5040 Gray (cGy) to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1
5
  83.3%
1 month
3
  50.0%
2 months
4
  66.7%
3 months
2
  33.3%
6 months
3
  50.0%
9 months
4
  66.7%
1 year
2
  33.3%
18 months
0
   0.0%
2 years
3
  50.0%
30 months
1
  16.7%
3 years
1
  16.7%
2.Primary Outcome
Title Maximum Tolerated Dose (MTD) of External Beam Radiation to Pelvic Lymph Nodes of Interest in Patients Receiving Radiation Therapy for Prostate Cancer (After the First 10 Patients) In Arm 1, Arm 2, and Arm 3
Hide Description Maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 or more in a cohort of either 3 or 6 patients experiences a dose limiting toxicity (DLT) attributed to radiation therapy. An acute DLT will be defined as Radiation Therapy Oncology Group (RTOG) grade 3 or greater, acute gastrointestinal or genitourinary toxicity within 3 months after the completion of radiation.
Time Frame Completion of Treatment, an average of 8.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The MTD of this study was not reached. The original principal investigator left the National Institutes of Health and we are unable to determine why the outcome was not met.
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGY to the Lymph Nodes
Hide Arm/Group Description:

5040 Gray (cGy) to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Grade 2 Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria
Hide Description Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Lower GI/Pelvis grade 2 toxicity Diarrhea requiring parasympatholytic drugs (e.g. Lomotil)/mucous discharge not necessitating sanitary pads/rectal or abdominal pain requiring analgesics and Genitourinary grade 2 defined as Frequency of urination or nocturia that is less frequent than every hour. Dysuria, urgency, bladder spasm requiring local anesthetic (e.g. Pyridium).
Time Frame At median follow-up, approximately 28 months following radiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes
Hide Arm/Group Description:

5040 Gray (cGy) to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5400cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5900cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

Overall Number of Participants Analyzed 12 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
Gastrointestinal
1
   8.3%
0
   0.0%
0
   0.0%
Genitourinary
3
  25.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With a Dose Limiting Toxicity (DLT)
Time Frame Within 3 months after completion of radiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes
Hide Arm/Group Description:

5040 Gray (cGy) to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5400cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5900cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

Overall Number of Participants Analyzed 12 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
Gastrointestinal
1
   8.3%
1
  33.3%
0
   0.0%
Genitourinary
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes
Hide Arm/Group Description:

5040 Gray (cGy) to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5400cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5900cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

Overall Number of Participants Analyzed 12 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
12
 100.0%
3
 100.0%
4
 100.0%
6.Secondary Outcome
Title Number of Participants With Grade 3 or 4 Acute and/or Late Gastrointestinal or Genitourinary Toxicity Assessed by the Radiation Oncology Group (RTOG) Criteria
Hide Description Long-term effects and toxicity following intensity modulated radiation therapy (IMRT) dose escalation to the pelvic nodes were measured by the Radiation Oncology Group (RTOG) Criteria. Grade 3 toxicity Lower GI/Pelvis is Diarrhea requiring parenteral support/severe mucous or blood discharge necessitating sanitary pads/abdominal distention (flat plate radiograph demonstrates distended bowel loops), Grade 3 toxicity Genitourinary Frequency with urgency and nocturia hourly or more frequently/dysuria, pelvis pain or bladder spasm requiring regular, frequent narcotic/gross hematuria with/without clot passage.
Time Frame At median follow-up, approximately 28 months following radiation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGY to the Lymph Nodes
Hide Arm/Group Description:

5040 Gray (cGy) to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5400cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.

5900cGy to the lymph nodes

Radiation will be given in dose escalations from 5040 Gray (cGY) to a maximum of 5900 cGy to lymph nodes.

Overall Number of Participants Analyzed 12 3 4
Measure Type: Count of Participants
Unit of Measure: Participants
Gastrointestinal
1
   8.3%
1
  33.3%
0
   0.0%
Genitourinary
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Date treatment consent signed to date off study, approximately 8 years and 3.5 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes
Hide Arm/Group Description

5040 Gray (cGy) to the lymph nodes

External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5400cGy to the lymph nodes

External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

5900cGy to the lymph nodes

External Beam Radiation: Radiation will be given in dose escalations from 5040 Gray (cGy) to a maximum of 5900 cGy to lymph nodes.

All-Cause Mortality
Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/3 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      1/3 (33.33%)      0/4 (0.00%)    
Gastrointestinal disorders       
Diarrhea  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations       
Infection with normal ANC or Grade 1 or 2 neutrophils::Liver  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
1
Term from vocabulary, CTC (3.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1- 5040cGy to the Lymph Nodes Arm 2 - 5400cGy to the Lymph Nodes Arm 3 - 5900cGy to the Lymph Nodes
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/12 (100.00%)      3/3 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders       
Leukocytes (total WBC)  1  1/12 (8.33%)  1 1/3 (33.33%)  1 3/4 (75.00%)  3
Lymphopenia  1  4/12 (33.33%)  4 2/3 (66.67%)  3 4/4 (100.00%)  12
PTT (Partial Thromboplastin Time)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Platelets  1  1/12 (8.33%)  1 0/3 (0.00%)  0 3/4 (75.00%)  3
Edema: limb  1  0/12 (0.00%)  0 2/3 (66.67%)  2 0/4 (0.00%)  0
Hemoglobin  1  5/12 (41.67%)  5 1/3 (33.33%)  1 1/4 (25.00%)  2
Neutrophils/granulocytes (ANC/AGC)  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Cardiac disorders       
Hypertension  1  2/12 (16.67%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0
Hypotension  1  1/12 (8.33%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0
Cardiac General - Other (heart murmur)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Endocrine disorders       
Hot flashes/flushes  1  9/12 (75.00%)  20 3/3 (100.00%)  4 2/4 (50.00%)  2
Endocrine - Other (breast tenderness)  1  2/12 (16.67%)  2 1/3 (33.33%)  1 0/4 (0.00%)  0
Endocrine - Other (® thyroid size increased)  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Gastrointestinal disorders       
Diarrhea  1  3/12 (25.00%)  4 0/3 (0.00%)  0 1/4 (25.00%)  3
Dysphagia (difficulty swallowing)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Flatulence  1  2/12 (16.67%)  2 0/3 (0.00%)  0 1/4 (25.00%)  2
Gastrointestinal - Other (Anal lesion - HPV virus (Bx on 1/28/18))  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (Diarrhea)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (Diarrhea, mucous discharge, abdo pain)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (Esophageal cancer)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (Urgency, abdominal pain)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (dysuria)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (frequency)  1  2/12 (16.67%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (increased bowel frequency)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (loose stools; frequency)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (mild BRBPR (hemorrhoids stable))  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (moderate diarrhea)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (moderate diarrhea, frequency, mucous)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (moderate frequency, urgency)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal - Other (rectal bleeding; urgency, frequent watery stools)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Hemorrhage, GI::Rectum  1  3/12 (25.00%)  4 0/3 (0.00%)  0 1/4 (25.00%)  2
Incontinence, anal  1  6/12 (50.00%)  9 0/3 (0.00%)  0 1/4 (25.00%)  1
Nausea  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Pain::Abdomen NOS  1  4/12 (33.33%)  6 1/3 (33.33%)  1 3/4 (75.00%)  4
Constipation  1  2/12 (16.67%)  2 1/3 (33.33%)  1 0/4 (0.00%)  0
Gastrointestinal - Other (Incontinence)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Gastrointestinal - Other (blood streaked stool)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Gastrointestinal - Other (loose stool, urgency)  1  1/12 (8.33%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0
Gastrointestinal - Other (loose stools)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 2/4 (50.00%)  2
Gastrointestinal - Other (small amount blood in stools)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Gastrointestinal - Other (urgency)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Hemorrhoids  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Proctitis  1  1/12 (8.33%)  1 1/3 (33.33%)  1 0/4 (0.00%)  0
Gastrointestinal - Other (frequency, soft BM's; mild abdo cramping)  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
General disorders       
Fatigue (asthenia, lethargy, malaise)  1  10/12 (83.33%)  16 2/3 (66.67%)  2 2/4 (50.00%)  2
Insomnia  1  1/12 (8.33%)  2 0/3 (0.00%)  0 0/4 (0.00%)  0
Weight gain  1  10/12 (83.33%)  17 2/3 (66.67%)  3 0/4 (0.00%)  0
Weight loss  1  6/12 (50.00%)  8 1/3 (33.33%)  1 1/4 (25.00%)  1
Edema: limb  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Immune system disorders       
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Infections and infestations       
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain - Other (L shoulder)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Pain - Other (R hip)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Pain - Other (Thoracic back pain)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Joint-function  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Pain::Back  1  3/12 (25.00%)  3 1/3 (33.33%)  1 0/4 (0.00%)  0
Pain::Joint  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Pain::Extremity-limb  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Nervous system disorders       
Mood alteration::Depression  1  3/12 (25.00%)  7 0/3 (0.00%)  0 0/4 (0.00%)  0
dizziness  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Renal and urinary disorders       
Cystitis  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Hemorrhage, GU::Urinary NOS  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Incontinence, urinary  1  4/12 (33.33%)  4 0/3 (0.00%)  0 1/4 (25.00%)  2
Renal/Genitourinary - Other (Dribbling)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Renal/Genitourinary - Other (Dysuria)  1  4/12 (33.33%)  5 0/3 (0.00%)  0 0/4 (0.00%)  0
Urinary frequency/urgency  1  0/12 (0.00%)  0 2/3 (66.67%)  2 3/4 (75.00%)  5
Urinary retention (including neurogenic bladder)  1  8/12 (66.67%)  10 2/3 (66.67%)  4 0/4 (0.00%)  0
Renal/Genitourinary - Other (Dysuria, Hematuria)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Renal/Genitourinary - Other (nocturia)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0
Hemorrhage, GU::Urethra  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Renal/Genitourinary - Other (Weak stream)  1  6/12 (50.00%)  10 3/3 (100.00%)  4 1/4 (25.00%)  1
Renal/Genitourinary - Other (dysuria, nocturia)  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1
Reproductive system and breast disorders       
Erectile dysfunction  1  8/12 (66.67%)  8 0/3 (0.00%)  0 1/4 (25.00%)  1
Gynecomastia  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Libido  1  4/12 (33.33%)  4 0/3 (0.00%)  0 0/4 (0.00%)  0
Orgasmic dysfunction  1  6/12 (50.00%)  6 0/3 (0.00%)  0 1/4 (25.00%)  1
Pain::Breast  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Pain::Pelvis  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/12 (8.33%)  1 0/3 (0.00%)  0 1/4 (25.00%)  1
Dyspnea (shortness of breath)  1  0/12 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1
Skin and subcutaneous tissue disorders       
Dermatology/Skin - Other (Penis mass)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Hair loss/alopecia (scalp or body)  1  3/12 (25.00%)  5 1/3 (33.33%)  1 0/4 (0.00%)  0
Hyperpigmentation  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Rash/desquamation  1  1/12 (8.33%)  2 0/3 (0.00%)  0 1/4 (25.00%)  1
Rash: acne/acneiform  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0
1
Term from vocabulary, CTC (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kevin Camphausen
Organization: National Cancer Institute
Phone: 240-760-6205
EMail: camphausen@nih.gov
Layout table for additonal information
Responsible Party: Kevin Camphausen, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00214422    
Obsolete Identifiers: NCT00278356
Other Study ID Numbers: 050241
05-C-0241
First Submitted: June 19, 2006
First Posted: September 21, 2005
Results First Submitted: October 30, 2018
Results First Posted: March 1, 2019
Last Update Posted: July 19, 2019