Trial Outcomes & Findings for Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme (NCT NCT01822275)

NCT ID: NCT01822275

Last Updated: 2022-12-29

Results Overview

Median survival (in months from time of diagnosis to date of death) was calculated and reported below. It is very difficult to draw efficacy outcomes for outcome measure #1 and #2 because of incomplete enrollment.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2022-12-29

Participant Flow

Participant milestones

Measure	Low Dose WBRT Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by either 6 or a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Chemotherapy with Temodar.: Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Radiation therapy
Overall Study STARTED	24
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	Low Dose WBRT Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by either 6 or a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Chemotherapy with Temodar.: Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Radiation therapy
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	3
Overall Study Progression	14
Overall Study Physician Decision	2

Baseline Characteristics

Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme

Baseline characteristics by cohort

Measure	Low Dose WBRT n=24 Participants Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by either 6 or a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Chemotherapy with Temodar.: Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Radiation therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	59.2 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Analysis was not done on efficacy of study since we were unable to meet the statistical requirements. 24 patients were accrued to the study, only 23 received treatment and were followed for adverse events. One patient was removed prior to treatment due to becoming a screen failure. Median survival rate for the 23 patients was calculated and results are below.

Median survival (in months from time of diagnosis to date of death) was calculated and reported below.

It is very difficult to draw efficacy outcomes for outcome measure #1 and #2 because of incomplete enrollment.

Outcome measures

Measure

Low Dose WBRT n=24 Participants Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by either 6 or a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Chemotherapy with Temodar.: Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Radiation therapy

Ability to Calculate the Efficacy of Low-dose Whole Brain RT (WBRT) in Patients With GBM

10 months Interval 4.0 to 50.0

SECONDARY outcome

Timeframe: 5 years

Population: 24 patients were accrued to the study, only 23 received treatment and were followed for adverse events. One patient was removed prior to receiving treatment due to becoming a screen failure. Outcome measure data represents the 4/23 (\~83%) patients that were free from distant failure when evaluating the above secondary outcome.

To determine the radiographic response and treatment failure patterns with the combination therapy. This would be measured through imaging that was collected from baseline to follow-up. If unable to meet statistical requirements, response assessment and treatment patterns will be unable to be determined.

It is very difficult to draw efficacy outcomes for outcome measure #1 and #2 because of incomplete enrollment.

Outcome measures

Measure

Low Dose WBRT n=24 Participants Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by either 6 or a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Chemotherapy with Temodar.: Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Radiation therapy

Radiographic (CT-MRI) Response Assessment and Treatment Failure Patterns of Patients With GBM

4 participants

Adverse Events

Low Dose WBRT

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Low Dose WBRT n=23 participants at risk Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by either 6 or a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Chemotherapy with Temodar.: Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Radiation therapy
Gastrointestinal disorders Constipation	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Fatigue	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Gait disturbance	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Infections and infestations Appendicitis	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Infections and infestations Urinary tract infection	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Lymphocyte count decreased	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Platelet count decreased	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations White blood cell decreased	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Dehydration	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hyperglycemia	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hyponatremia	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Edema cerebral	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Headache	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Hydrocephalus	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Seizure	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Vascular disorders Hypertension	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Vascular disorders Thromboembolic event	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.

Other adverse events

Measure	Low Dose WBRT n=23 participants at risk Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by either 6 or a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Chemotherapy with Temodar.: Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar. Radiation therapy
Blood and lymphatic system disorders Anemia	30.4% 7/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Ear and labyrinth disorders Ear pain	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Ear and labyrinth disorders External ear pain	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Ear and labyrinth disorders Hearing impaired	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Ear and labyrinth disorders Tinnitus	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Endocrine disorders Cushingoid	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Eye disorders Blurred vision	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Eye disorders Eye disorders - Other, specify	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Eye disorders Eye pain	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Eye disorders Flashing lights	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Eye disorders Watering eyes	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Constipation	39.1% 9/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Diarrhea	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Dyspepsia	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Dysphagia	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Hemorrhoids	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Mucositis oral	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Nausea	73.9% 17/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Gastrointestinal disorders Vomiting	21.7% 5/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Edema face	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Edema limbs	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Fatigue	65.2% 15/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Fever	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Flu like symptoms	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Gait disturbance	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders General disorders and administration site conditions - Other, specify	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Localized edema	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
General disorders Pain	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Infections and infestations Lip infection	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Infections and infestations Lung infection	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Infections and infestations Urinary tract infection	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Injury, poisoning and procedural complications Dermatitis radiation	39.1% 9/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Injury, poisoning and procedural complications Fall	26.1% 6/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Alanine aminotransferase increased	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Alkaline phosphatase increased	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Aspartate aminotransferase increased	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Creatinine increased	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Neutrophil count decreased	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Platelet count decreased	60.9% 14/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations Weight loss	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Investigations White blood cell decreased	39.1% 9/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Anorexia	26.1% 6/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Dehydration	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hypercalcemia	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hyperglycemia	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hypernatremia	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hypertriglyceridemia	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hypoalbuminemia	17.4% 4/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hypocalcemia	30.4% 7/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hypoglycemia	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hypokalemia	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hyponatremia	26.1% 6/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Metabolism and nutrition disorders Hypophosphatemia	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Arthralgia	21.7% 5/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Arthritis	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Back pain	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	17.4% 4/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Myalgia	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Musculoskeletal and connective tissue disorders Neck pain	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Amnesia	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Ataxia	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Dizziness	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Dysgeusia	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Edema cerebral	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Extrapyramidal disorder	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Headache	82.6% 19/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Hydrocephalus	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Memory impairment	26.1% 6/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Nervous system disorders - Other, specify	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Neuralgia	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Nystagmus	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Peripheral motor neuropathy	26.1% 6/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Seizure	26.1% 6/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Nervous system disorders Tremor	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Psychiatric disorders Anxiety	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Psychiatric disorders Confusion	17.4% 4/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Psychiatric disorders Delirium	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Psychiatric disorders Depression	26.1% 6/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Psychiatric disorders Insomnia	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Psychiatric disorders Personality change	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Renal and urinary disorders Bladder spasm	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Renal and urinary disorders Hematuria	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Renal and urinary disorders Urinary tract pain	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Reproductive system and breast disorders Erectile dysfunction	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Respiratory, thoracic and mediastinal disorders Cough	17.4% 4/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Respiratory, thoracic and mediastinal disorders Hiccups	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Respiratory, thoracic and mediastinal disorders Wheezing	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Skin and subcutaneous tissue disorders Alopecia	56.5% 13/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Skin and subcutaneous tissue disorders Dry skin	8.7% 2/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Skin and subcutaneous tissue disorders Erythema multiforme	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Skin and subcutaneous tissue disorders Erythroderma	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Skin and subcutaneous tissue disorders Rash acneiform	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	13.0% 3/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	26.1% 6/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Vascular disorders Hypertension	56.5% 13/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Vascular disorders Lymphedema	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.
Vascular disorders Superficial thrombophlebitis	4.3% 1/23 • Adverse Events were collected during their approximately 6 weeks radiation period and their 6-12 month period of temodar. Adverse Events were then evaluated for at each follow-up per the protocol. Patients were followed until progression or death. 24 patients were accrued to the study, however only 23 received treatment and were followed for adverse events. The one patient was removed prior to receiving study treatment due to becoming a screen failure. All patients were removed from study due to progression or adverse events. No deaths occurred on study.

Additional Information

Caitlin Eggleston

University of Maryland Medical Center

Phone: 4103287586

Email: caitlineggleston@umm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place