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Observation or Radiation Therapy in Treating Patients With Grade I, Grade II, or Grade III Meningioma

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: NCT00895622
Recruitment Status : Active, not recruiting
First Posted : May 8, 2009
Results First Posted : January 19, 2018
Last Update Posted : June 10, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Brain and Central Nervous System Tumors
Interventions Radiation: 54 Gy radiotherapy
Radiation: 60 Gy radiotherapy
Enrollment 244
Recruitment Details  
Pre-assignment Details Two hundred forty-four patients registered for the first step registration which consisted of central pathology review confirmation of histology. One hundred seventy-eight continued on to the second step registration.
Arm/Group Title Low Risk Intermidiate Risk High Risk
Hide Arm/Group Description No treatment given 54 Gy radiotherapy 60 Gy radiotherapy
Period Title: Overall Study
Started 65 56 57
Completed 60 52 53
Not Completed 5 4 4
Reason Not Completed
Protocol Violation             5             4             4
Arm/Group Title Low Risk Intermidiate Risk High Risk Total
Hide Arm/Group Description No treatment given 54 Gy radiotherapy 60 Gy radiotherapy Total of all reporting groups
Overall Number of Baseline Participants 60 52 53 165
Hide Baseline Analysis Population Description
All eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants 52 participants 53 participants 165 participants
56
(31 to 79)
53
(18 to 73)
62
(19 to 94)
56
(18 to 94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 52 participants 53 participants 165 participants
Female
48
  80.0%
32
  61.5%
28
  52.8%
108
  65.5%
Male
12
  20.0%
20
  38.5%
25
  47.2%
57
  34.5%
1.Primary Outcome
Title Progression-free Survival Rate at 3 Years
Hide Description Progression was determined by central review of magnetic resonance imaging (MRI) exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival (PFS) rates are estimated using the binomial method.
Time Frame From registration to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and evaluable for 3-year progression-free survival
Arm/Group Title Low Risk Intermidiate Risk High Risk
Hide Arm/Group Description:
No treatment given
54 Gy radiotherapy
60 Gy radiotherapy
Overall Number of Participants Analyzed 51 48 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.2
(81.1 to 97.8)
93.7
(82.8 to 98.7)
58.8
(44.2 to 72.4)
2.Secondary Outcome
Title Number of Patients With Grades 2-5 Acute Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]
Hide Description Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Time Frame From start of radiation to 90 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment with acute AE assessed. Low risk patients are not reported since they did not receive any study treatment.
Arm/Group Title Intermidiate Risk High Risk
Hide Arm/Group Description:
54 Gy radiotherapy
60 Gy radiotherapy
Overall Number of Participants Analyzed 46 53
Measure Type: Count of Participants
Unit of Measure: Participants
Neurology Grade 2
4
   8.7%
3
   5.7%
Grade 3
0
   0.0%
2
   3.8%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
None Grade 2-5
42
  91.3%
48
  90.6%
Ocular/visual Grade 2
1
   2.2%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
None Grade 2-5
45
  97.8%
53
 100.0%
Dermatology/Skin Grade 2
1
   2.2%
2
   3.8%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
None Grade 2-5
45
  97.8%
51
  96.2%
Groups combined Grade 2
5
  10.9%
4
   7.5%
Grade 3
0
   0.0%
2
   3.8%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
None Grade 2-5
41
  89.1%
47
  88.7%
3.Secondary Outcome
Title Number of Patients With Grades 2-5 Late Adverse Events in the Following Categories Individually and Combined: Neurology, Ocular/Visual, Dermatologic/Skin [Excluding Alopecia]
Hide Description Grades 2-5 neurology, ocular/visual, dermatologic/skin [excluding alopecia] categories, individually and combined for acute adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 where the attribution is related to treatment as definite, probable, possible, or unknown. Late adverse events are those occurring more than 90 days from start of radiation therapy.
Time Frame Ninety-one days from start of radiation therapy to last follow-up. Maximum follow-up at time of analysis was 6.3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment with acute AE assessed. Low risk patients are not reported since they did not receive any study treatment.
Arm/Group Title Intermidiate Risk High Risk
Hide Arm/Group Description:
54 Gy radiotherapy
60 Gy radiotherapy
Overall Number of Participants Analyzed 51 51
Measure Type: Count of Participants
Unit of Measure: Participants
Neurology Grade 2
12
  23.5%
11
  21.6%
Grade 3
0
   0.0%
3
   5.9%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
1
   2.0%
None Grade 2-5
39
  76.5%
36
  70.6%
Ocular/visual Grade 2
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
None Grade 2-5
51
 100.0%
51
 100.0%
Dermatology/Skin Grade 2
1
   2.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
None Grade 2-5
50
  98.0%
51
 100.0%
Groups combined Grade 2
13
  25.5%
11
  21.6%
Grade 3
0
   0.0%
3
   5.9%
Grade 4
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
1
   2.0%
None Grade 2-5
38
  74.5%
36
  70.6%
4.Secondary Outcome
Title Overall Survival Rate at 3 Years
Hide Description Overall survival time is defined as time from randomization to 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.
Time Frame From registration to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment
Arm/Group Title Low Risk Intermidiate Risk High Risk
Hide Arm/Group Description:
No treatment given
54 Gy radiotherapy
60 Gy radiotherapy
Overall Number of Participants Analyzed 52 48 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.1
(89.7 to 100.0)
95.8
(85.8 to 99.5)
78.4
(64.7 to 88.7)
5.Secondary Outcome
Title Progression-free Survival Rate at 3 Years (Kaplan-Meier Method)
Hide Description Progression was determined by central review of MRI exams and is defined as an increase in measurable tumor of greater than 20% in any diameter, or as new nodular enhancement in patients with no measurable tumor on initial postoperative imaging. In the absence of neurologic progression (NP), suspected imaging progression of less than 5 mm (maximum diameter) must be confirmed on two successive follow-up MRI studies, a minimum of 3 months apart. NP is defined as a new or progressive neurologic deficit attributed to the meningioma, with or without measurable meningioma growth. Progression-free survival time is defined as time from registration to the date of progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method.
Time Frame From registration to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started study treatment and evaluable for 3-year progression-free survival
Arm/Group Title Low Risk Intermidiate Risk High Risk
Hide Arm/Group Description:
No treatment given
54 Gy radiotherapy
60 Gy radiotherapy
Overall Number of Participants Analyzed 60 52 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.4
(84.2 to 98.6)
93.9
(87.2 to 100.0)
59.2
(45.7 to 72.6)
6.Secondary Outcome
Title Number of Participants Determined to Have MRI Imaging Features as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years
Hide Description MRI's were centrally reviewed by the study neuroradiology co-chairs for presence of edema, homogeneous enhancement, calcification, hyperostosis, and brain invasion. Data is presented for all risk groups combined, with time points presented in each column. Neither risk groups nor time points are compared.
Time Frame Baseline, at time of first progression, and at 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who started study treatment, had a centrally reviewed MRI at the given time, and whose MRI was evaluable for the given feature
Arm/Group Title MRI at Diagnosis MRI at First Progression MRI at 3 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 148 23 79
Measure Type: Count of Participants
Unit of Measure: Participants
Edema Number Analyzed 114 participants 18 participants 39 participants
76
  66.7%
13
  72.2%
15
  38.5%
Homogeneous Enhancement Number Analyzed 116 participants 12 participants 33 participants
88
  75.9%
9
  75.0%
14
  42.4%
Calcification Number Analyzed 27 participants 5 participants 20 participants
6
  22.2%
0
   0.0%
1
   5.0%
Hyperostosis Number Analyzed 40 participants 5 participants 20 participants
17
  42.5%
0
   0.0%
1
   5.0%
Brain Invasion Number Analyzed 30 participants 8 participants 22 participants
1
   3.3%
0
   0.0%
1
   4.5%
7.Secondary Outcome
Title Greatest Single Dimension From MRI as Assessed by Central Neuroradiology Review at Diagnosis, at Progression, and at 3 Years
Hide Description MRI's were centrally reviewed by the study neuroradiology co-chairs. Data is presented for all risk groups combined, with time points presented in each column. Neither risk groups nor time points are compared.
Time Frame Baseline, at time of first progression, and at 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who started study treatment, had a centrally reviewed MRI at the given time, and whose MRI was evaluable for tumor dimension.
Arm/Group Title MRI at Diagnosis MRI at First Progression MRI at 3 Years
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 148 21 28
Median (Full Range)
Unit of Measure: milimeters
42.7
(4.2 to 144.4)
34.7
(14.0 to 104.0)
29.0
(7.5 to 129.9)
8.Secondary Outcome
Title Adherence to Protocol-specific Target and Normal Tissue Radiotherapy Parameters
Hide Description The principle investigator performed a radiotherapy quality assurance (QA) review.
Time Frame After treatment delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible participants who started treatment and were centrally reviewed
Arm/Group Title Intermidiate Risk High Risk
Hide Arm/Group Description:
54 Gy radiotherapy
60 Gy radiotherapy
Overall Number of Participants Analyzed 44 46
Measure Type: Count of Participants
Unit of Measure: Participants
Per protocol
36
  81.8%
39
  84.8%
Acceptable variation
4
   9.1%
5
  10.9%
Unacceptable deviation
2
   4.5%
1
   2.2%
Not evaluable
2
   4.5%
1
   2.2%
9.Secondary Outcome
Title Concordance Between Central and Parent Institution Histopathologic Grading/Subtyping
Hide Description A pathology review was conducted both by the institution and centrally, with three possible choices for grade / subtype: World Health Organization (WHO) Grade I / benign; WHO grade II / atypical; WHO grade III / anaplastic. Data is presented for all risk groups combined.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients with central and site reviews
Arm/Group Title Central Review: Benign Central Review: Atypical Central Review: Anaplastic
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 76 71 25
Measure Type: Count of Participants
Unit of Measure: Participants
Site Review: Benign
74
  97.4%
9
  12.7%
1
   4.0%
Site Review: Atypical
2
   2.6%
60
  84.5%
8
  32.0%
Site Review: Anaplastic
0
   0.0%
2
   2.8%
16
  64.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Central Review: Benign, Central Review: Atypical, Central Review: Anaplastic
Comments

The Kappa (κ) coefficient was used to assess the measure of agreement between the reviewers. κ can be interpreted as follows (κ / Agreement):

< 0 / Less than chance agreement; 0.01-0.20 / Slight agreement; 0.21-0.40 / Fair agreement; 0.41-0.60 / Moderate agreement; 0.61-0.80 / Substantial agreement; 0.81-0.99 / Almost perfect agreement.

The asymptotic test of the null hypothesis: κ=0 will be performed using the Z-statistic to determine the strength of agreement.

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Z test
Comments [Not Specified]
Method of Estimation Estimation Parameter Kappa statistic
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.71 to 0.87
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Molecular Correlative Studies
Hide Description [Not Specified]
Time Frame From registration to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG Oncology tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
Arm/Group Title Intermidiate Risk High Risk
Hide Arm/Group Description:
54 Gy radiotherapy
60 Gy radiotherapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Histopathologic Correlates of PFS Including Light Microscopy, Immunohistochemical Analysis, and Microarray Analysis
Hide Description [Not Specified]
Time Frame From registration to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
Arm/Group Title Intermidiate Risk High Risk
Hide Arm/Group Description:
54 Gy radiotherapy
60 Gy radiotherapy
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Eligible patients who started protocol treatment. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Low Risk Intermidiate Risk High Risk
Hide Arm/Group Description No treatment given 54 Gy radiotherapy 60 Gy radiotherapy
All-Cause Mortality
Low Risk Intermidiate Risk High Risk
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/60 (36.67%)   47/52 (90.38%)   47/53 (88.68%) 
Hide Serious Adverse Events
Low Risk Intermidiate Risk High Risk
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   1/52 (1.92%)   5/53 (9.43%) 
General disorders       
Gait abnormal * 1  0/60 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Pain [other] * 1  0/60 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Infections and infestations       
Soft tissue infection [with normal or Grade 1-2 ANC] * 1  0/60 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Nervous system disorders       
Central nervous system necrosis * 1  0/60 (0.00%)  1/52 (1.92%)  1/53 (1.89%) 
Neurological disorder NOS * 1  0/60 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Peripheral sensory neuropathy * 1  0/60 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Seizure * 1  0/60 (0.00%)  0/52 (0.00%)  2/53 (3.77%) 
Tremor * 1  0/60 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
Vascular disorders       
Hypertension * 1  0/60 (0.00%)  0/52 (0.00%)  1/53 (1.89%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Risk Intermidiate Risk High Risk
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/60 (36.67%)   47/52 (90.38%)   47/53 (88.68%) 
Blood and lymphatic system disorders       
Hemoglobin decreased * 1  0/60 (0.00%)  1/52 (1.92%)  6/53 (11.32%) 
Ear and labyrinth disorders       
Hearing loss * 1  0/60 (0.00%)  8/52 (15.38%)  4/53 (7.55%) 
Tinnitus * 1  0/60 (0.00%)  4/52 (7.69%)  0/53 (0.00%) 
Eye disorders       
Eye disorder * 1  1/60 (1.67%)  5/52 (9.62%)  3/53 (5.66%) 
Flashing vision * 1  0/60 (0.00%)  3/52 (5.77%)  1/53 (1.89%) 
Vision blurred * 1  2/60 (3.33%)  7/52 (13.46%)  6/53 (11.32%) 
Gastrointestinal disorders       
Constipation * 1  0/60 (0.00%)  4/52 (7.69%)  5/53 (9.43%) 
Diarrhea * 1  0/60 (0.00%)  4/52 (7.69%)  2/53 (3.77%) 
Dyspepsia * 1  0/60 (0.00%)  3/52 (5.77%)  2/53 (3.77%) 
Nausea * 1  0/60 (0.00%)  11/52 (21.15%)  11/53 (20.75%) 
Vomiting * 1  0/60 (0.00%)  5/52 (9.62%)  1/53 (1.89%) 
General disorders       
Edema limbs * 1  0/60 (0.00%)  0/52 (0.00%)  4/53 (7.55%) 
Fatigue * 1  5/60 (8.33%)  34/52 (65.38%)  29/53 (54.72%) 
Gait abnormal * 1  0/60 (0.00%)  1/52 (1.92%)  5/53 (9.43%) 
General symptom * 1  0/60 (0.00%)  3/52 (5.77%)  0/53 (0.00%) 
Injury, poisoning and procedural complications       
Dermatitis radiation * 1  0/60 (0.00%)  6/52 (11.54%)  9/53 (16.98%) 
Radiation recall reaction (dermatologic) * 1  0/60 (0.00%)  2/52 (3.85%)  8/53 (15.09%) 
Investigations       
Lymphocyte count decreased * 1  0/60 (0.00%)  0/52 (0.00%)  4/53 (7.55%) 
Platelet count decreased * 1  1/60 (1.67%)  1/52 (1.92%)  4/53 (7.55%) 
Weight loss * 1  0/60 (0.00%)  5/52 (9.62%)  2/53 (3.77%) 
Metabolism and nutrition disorders       
Anorexia * 1  0/60 (0.00%)  7/52 (13.46%)  6/53 (11.32%) 
Blood glucose increased * 1  1/60 (1.67%)  0/52 (0.00%)  7/53 (13.21%) 
Serum albumin decreased * 1  0/60 (0.00%)  0/52 (0.00%)  4/53 (7.55%) 
Serum calcium decreased * 1  0/60 (0.00%)  0/52 (0.00%)  4/53 (7.55%) 
Serum potassium decreased * 1  1/60 (1.67%)  0/52 (0.00%)  4/53 (7.55%) 
Serum sodium decreased * 1  0/60 (0.00%)  0/52 (0.00%)  3/53 (5.66%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  2/60 (3.33%)  4/52 (7.69%)  3/53 (5.66%) 
Muscle weakness * 1  0/60 (0.00%)  0/52 (0.00%)  3/53 (5.66%) 
Musculoskeletal disorder * 1  0/60 (0.00%)  0/52 (0.00%)  5/53 (9.43%) 
Neck pain * 1  2/60 (3.33%)  3/52 (5.77%)  0/53 (0.00%) 
Pain in extremity * 1  1/60 (1.67%)  4/52 (7.69%)  2/53 (3.77%) 
Nervous system disorders       
Ataxia * 1  1/60 (1.67%)  3/52 (5.77%)  3/53 (5.66%) 
Central nervous system necrosis * 1  0/60 (0.00%)  0/52 (0.00%)  3/53 (5.66%) 
Cognitive disturbance * 1  1/60 (1.67%)  3/52 (5.77%)  7/53 (13.21%) 
Dizziness * 1  5/60 (8.33%)  14/52 (26.92%)  9/53 (16.98%) 
Headache * 1  10/60 (16.67%)  25/52 (48.08%)  21/53 (39.62%) 
Memory impairment * 1  4/60 (6.67%)  8/52 (15.38%)  14/53 (26.42%) 
Neurological disorder NOS * 1  1/60 (1.67%)  1/52 (1.92%)  7/53 (13.21%) 
Olfactory nerve disorder * 1  0/60 (0.00%)  3/52 (5.77%)  0/53 (0.00%) 
Peripheral motor neuropathy * 1  1/60 (1.67%)  3/52 (5.77%)  3/53 (5.66%) 
Peripheral sensory neuropathy * 1  5/60 (8.33%)  6/52 (11.54%)  7/53 (13.21%) 
Seizure * 1  4/60 (6.67%)  7/52 (13.46%)  14/53 (26.42%) 
Speech disorder * 1  2/60 (3.33%)  3/52 (5.77%)  8/53 (15.09%) 
Taste alteration * 1  0/60 (0.00%)  3/52 (5.77%)  6/53 (11.32%) 
Tremor * 1  0/60 (0.00%)  1/52 (1.92%)  3/53 (5.66%) 
Psychiatric disorders       
Anxiety * 1  3/60 (5.00%)  2/52 (3.85%)  3/53 (5.66%) 
Depression * 1  4/60 (6.67%)  4/52 (7.69%)  8/53 (15.09%) 
Insomnia * 1  2/60 (3.33%)  4/52 (7.69%)  2/53 (3.77%) 
Renal and urinary disorders       
Urinary frequency * 1  0/60 (0.00%)  3/52 (5.77%)  2/53 (3.77%) 
Urinary incontinence * 1  0/60 (0.00%)  0/52 (0.00%)  6/53 (11.32%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  0/60 (0.00%)  28/52 (53.85%)  32/53 (60.38%) 
Dry skin * 1  0/60 (0.00%)  1/52 (1.92%)  3/53 (5.66%) 
Pruritus * 1  0/60 (0.00%)  2/52 (3.85%)  5/53 (9.43%) 
Rash desquamating * 1  0/60 (0.00%)  0/52 (0.00%)  3/53 (5.66%) 
Scalp pain * 1  3/60 (5.00%)  0/52 (0.00%)  3/53 (5.66%) 
Skin disorder * 1  0/60 (0.00%)  2/52 (3.85%)  3/53 (5.66%) 
Skin hyperpigmentation * 1  0/60 (0.00%)  4/52 (7.69%)  5/53 (9.43%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
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
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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00895622    
Other Study ID Numbers: RTOG-0539
CDR0000641815
First Submitted: May 7, 2009
First Posted: May 8, 2009
Results First Submitted: December 18, 2017
Results First Posted: January 19, 2018
Last Update Posted: June 10, 2021