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Hormone Therapy and Radiation Therapy in Treating Patients With 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: NCT00005044
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : October 31, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Casodex
Drug: Eulexin
Drug: LHRH agonist
Radiation: radiation therapy
Enrollment 1579
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin). TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Period Title: Overall Study
Started 790 789
Completed 752 [1] 737 [1]
Not Completed 38 52
Reason Not Completed
Protocol Violation             37             46
Withdrawal by Subject             1             5
No protocol treatment             0             1
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks Total
Hide Arm/Group Description Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin). TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin). Total of all reporting groups
Overall Number of Baseline Participants 752 737 1489
Hide Baseline Analysis Population Description
Eligible patients with follow-up data
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 752 participants 737 participants 1489 participants
71
(45 to 84)
71
(46 to 88)
71
(45 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 752 participants 737 participants 1489 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
752
 100.0%
737
 100.0%
1489
 100.0%
1.Primary Outcome
Title Disease-specific Survival (DSS) (10-year Rates Reported)
Hide Description Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.
Time Frame From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with follow-up data
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description:
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Overall Number of Participants Analyzed 752 737
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95
(93 to 97)
96
(95 to 98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAS x 8 Weeks, TAS x 28 Weeks
Comments Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.48 to 1.39
Estimation Comments Reference level = TAS x 8 weeks
2.Secondary Outcome
Title Overall Survival (OS) (10-year Rates Reported)
Hide Description Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
Time Frame From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with follow-up data
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description:
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Overall Number of Participants Analyzed 752 737
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66
(62 to 70)
67
(63 to 71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAS x 8 Weeks, TAS x 28 Weeks
Comments With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level of 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.79 to 1.15
Estimation Comments Reference level = TAS x 8 weeks
3.Secondary Outcome
Title Disease-free Survival (DFS) (10-year Rates Reported)
Hide Description Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.
Time Frame From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients without follow-up data
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description:
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Overall Number of Participants Analyzed 752 737
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24
(20 to 27)
23
(20 to 27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAS x 8 Weeks, TAS x 28 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Log Rank
Comments Significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.85 to 1.08
Estimation Comments Reference level = TAS x 8 weeks
4.Secondary Outcome
Title Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)
Hide Description Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF [protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.
Time Frame From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with follow-up data
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description:
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Overall Number of Participants Analyzed 752 737
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Locoregional progression
6
(4 to 8)
4
(3 to 6)
Distant metastasis
6
(4 to 8)
6
(4 to 8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAS x 8 Weeks, TAS x 28 Weeks
Comments Locoregional progression
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Gray's test
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.40 to 1.05
Estimation Comments Reference level = TAS x 8 weeks
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAS x 8 Weeks, TAS x 28 Weeks
Comments Distant metastasis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Gray's test
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.68 to 1.66
Estimation Comments Reference level = TAS x 8 weeks
5.Secondary Outcome
Title Time to First Biochemical Failure (BF) (10-year Rates Reported)
Hide Description

Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored.

Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported.

Time Frame From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with follow-up data
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description:
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Overall Number of Participants Analyzed 752 737
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Protocol definition
56
(52 to 59)
59
(56 to 63)
Phoenix definition
27
(23 to 30)
27
(23 to 30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAS x 8 Weeks, TAS x 28 Weeks
Comments Protocol definition
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Gray's test
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.89 to 1.17
Estimation Comments Reference level = TAS x 8 weeks
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection TAS x 8 Weeks, TAS x 28 Weeks
Comments Phoenix definition
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Gray's test
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.79 to 1.19
Estimation Comments Reference level = TAS x 8 weeks
6.Secondary Outcome
Title Time to Second Biochemical Failure (SBF) (10-year Rates Reported)
Hide Description Time to SBF measured from date of randomization to the date of PSA increase of ≥1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.
Time Frame From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with follow-up data
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description:
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Overall Number of Participants Analyzed 752 737
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10
(7 to 12)
9
(7 to 12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAS x 8 Weeks, TAS x 28 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.64 to 1.30
Estimation Comments Reference level = TAS x 8 weeks
7.Secondary Outcome
Title Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)
Hide Description Acute drug therapy and radiation (<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.
Time Frame From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with adverse event data in corresponding time frame (during hormone therapy and <=90 days from RT start; > 90 days from RT start)
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description:
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Overall Number of Participants Analyzed 747 735
Measure Type: Number
Unit of Measure: percentage of participants
Acute RT and Hormone Toxicity: Grade 1 Number Analyzed 747 participants 735 participants
30.8 19.5
Acute RT and Hormone Toxicity: Grade 2 Number Analyzed 747 participants 735 participants
41.6 49.8
Acute RT and Hormone Toxicity: Grade 3 Number Analyzed 747 participants 735 participants
16.1 25.7
Acute RT and Hormone Toxicity: Grade 4 Number Analyzed 747 participants 735 participants
0 0.1
Acute RT and Hormone Toxicity: Grade 5 Number Analyzed 747 participants 735 participants
0 0
Late RT Toxicity: Grade 1 Number Analyzed 742 participants 724 participants
34.0 32.9
Late RT Toxicity: Grade 2 Number Analyzed 742 participants 724 participants
20.5 22.5
Late RT Toxicity: Grade 3 Number Analyzed 742 participants 724 participants
9.7 8.0
Late RT Toxicity: Grade 4 Number Analyzed 742 participants 724 participants
0.1 0.3
Late RT Toxicity: Grade 5 Number Analyzed 742 participants 724 participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description Eligible patients with adverse event data are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title TAS x 8 Weeks TAS x 28 Weeks
Hide Arm/Group Description Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin). TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
All-Cause Mortality
TAS x 8 Weeks TAS x 28 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TAS x 8 Weeks TAS x 28 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   121/747 (16.20%)   109/735 (14.83%) 
Cardiac disorders     
Arrhythmia NOS * 1  1/747 (0.13%)  0/735 (0.00%) 
Supraventricular arrhythmia NOS * 1  0/747 (0.00%)  1/735 (0.14%) 
Gastrointestinal disorders     
Diarrhea NOS  1  12/747 (1.61%)  18/735 (2.45%) 
Gastritis NOS * 1  0/747 (0.00%)  1/735 (0.14%) 
Late RT Toxicity: Other GI: NOS  2  10/747 (1.34%)  3/735 (0.41%) 
Late RT Toxicity: Small/Large Intestine: NOS  2  9/747 (1.20%)  8/735 (1.09%) 
Proctalgia * 1  0/747 (0.00%)  1/735 (0.14%) 
Proctitis NOS  1  1/747 (0.13%)  1/735 (0.14%) 
Vomiting NOS * 1  1/747 (0.13%)  0/735 (0.00%) 
General disorders     
Late RT Toxicity: Other: NOS  2  24/747 (3.21%)  26/735 (3.54%) 
Pain-other * 1  1/747 (0.13%)  0/735 (0.00%) 
Hepatobiliary disorders     
Hepatic-Other * 1  0/747 (0.00%)  1/735 (0.14%) 
Infections and infestations     
Infection with unknown ANC * 1  0/747 (0.00%)  1/735 (0.14%) 
Infection, Other * 1  0/747 (0.00%)  1/735 (0.14%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS  1  1/747 (0.13%)  0/735 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  15/747 (2.01%)  4/735 (0.54%) 
Aspartate aminotransferase increased * 1  4/747 (0.54%)  0/735 (0.00%) 
Blood bilirubin increased  1  1/747 (0.13%)  0/735 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/747 (0.00%)  1/735 (0.14%) 
Platelet count decreased * 1  0/747 (0.00%)  1/735 (0.14%) 
Metabolism and nutrition disorders     
Anorexia * 1  1/747 (0.13%)  0/735 (0.00%) 
Dehydration * 1  1/747 (0.13%)  0/735 (0.00%) 
Hyperglycemia NOS * 1  2/747 (0.27%)  3/735 (0.41%) 
Hypoglycaemia NOS * 1  1/747 (0.13%)  0/735 (0.00%) 
Hypokalemia * 1  1/747 (0.13%)  0/735 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain * 1  1/747 (0.13%)  0/735 (0.00%) 
Myositis * 1  0/747 (0.00%)  1/735 (0.14%) 
Nervous system disorders     
Cerebral ischaemia * 1  0/747 (0.00%)  1/735 (0.14%) 
Headache NOS * 1  0/747 (0.00%)  1/735 (0.14%) 
Peripheral motor neuropathy * 1  1/747 (0.13%)  0/735 (0.00%) 
Syncope * 1  0/747 (0.00%)  1/735 (0.14%) 
Renal and urinary disorders     
Dysuria * 1  6/747 (0.80%)  1/735 (0.14%) 
Late RT Toxicity: Bladder: NOS  2  33/747 (4.42%)  24/735 (3.27%) 
Renal/GU-Other * 1  1/747 (0.13%)  2/735 (0.27%) 
Urinary retention * 1  1/747 (0.13%)  1/735 (0.14%) 
Reproductive system and breast disorders     
Gynaecomastia  1  0/747 (0.00%)  1/735 (0.14%) 
Late RT Toxicity: Other GU: NOS  2  21/747 (2.81%)  25/735 (3.40%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome * 1  0/747 (0.00%)  1/735 (0.14%) 
Dyspnea NOS * 1  2/747 (0.27%)  1/735 (0.14%) 
Pulmonary-other * 1  0/747 (0.00%)  1/735 (0.14%) 
Skin and subcutaneous tissue disorders     
Dermatitis exfoliative NOS * 1  0/747 (0.00%)  1/735 (0.14%) 
Late RT Toxicity: Skin: NOS  2  0/747 (0.00%)  1/735 (0.14%) 
Vascular disorders     
Hypertension NOS * 1  0/747 (0.00%)  1/735 (0.14%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TAS x 8 Weeks TAS x 28 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   695/747 (93.04%)   707/735 (96.19%) 
Gastrointestinal disorders     
Constipation * 1  25/747 (3.35%)  42/735 (5.71%) 
Diarrhea NOS  1  238/747 (31.86%)  245/735 (33.33%) 
Late RT Toxicity: Other GI: NOS  2  135/747 (18.07%)  159/735 (21.63%) 
Late RT Toxicity: Small/Large Intestine: NOS  2  194/747 (25.97%)  196/735 (26.67%) 
Proctitis NOS  1  173/747 (23.16%)  164/735 (22.31%) 
General disorders     
Late RT Toxicity: Other: NOS  2  113/747 (15.13%)  124/735 (16.87%) 
Fatigue * 1  159/747 (21.29%)  224/735 (30.48%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS  1  103/747 (13.79%)  89/735 (12.11%) 
Investigations     
Alanine aminotransferase increased  1  92/747 (12.32%)  104/735 (14.15%) 
Blood bilirubin increased  1  30/747 (4.02%)  41/735 (5.58%) 
Psychiatric disorders     
Libido decreased * 1  17/747 (2.28%)  51/735 (6.94%) 
Renal and urinary disorders     
Dysuria * 1  82/747 (10.98%)  85/735 (11.56%) 
Late RT Toxicity: Bladder: NOS  2  260/747 (34.81%)  270/735 (36.73%) 
Urinary frequency  1  444/747 (59.44%)  456/735 (62.04%) 
Reproductive system and breast disorders     
Gynaecomastia  1  34/747 (4.55%)  107/735 (14.56%) 
Impotence * 1  64/747 (8.57%)  132/735 (17.96%) 
Late RT Toxicity: Other GU: NOS  2  191/747 (25.57%)  194/735 (26.39%) 
Vascular disorders     
Menopausal symptoms  1  458/747 (61.31%)  596/735 (81.09%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
The data monitoring committee decided in June 2012 after the first interim analysis that the trial should be reported early due to the low number of events.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00005044     History of Changes
Other Study ID Numbers: RTOG-9910
CDR0000067635
First Submitted: April 6, 2000
First Posted: January 27, 2003
Results First Submitted: October 2, 2017
Results First Posted: October 31, 2017
Last Update Posted: June 11, 2019