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Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

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ClinicalTrials.gov Identifier: NCT00068250
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
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: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain and Central Nervous System Tumors
Lymphoma
Interventions Drug: rituximab
Drug: methotrexate
Drug: temozolomide 100 mg/m^2
Drug: temozolomide 150 mg/m^2
Drug: temozolomide 200 mg/m^2
Radiation: radiation therapy
Drug: post-radiation therapy temozolomide
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I: Temozolomide 100 mg Phase I: Temozolomide 150 mg Phase I: Temozolomide 200 mg Phase II: Temozolomide 100 mg
Hide Arm/Group Description Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Rituximab, methotrexate, temozolomide 200 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
Period Title: Phase I: Dose Level 1
Started 6 0 0 0
Completed 6 [1] 0 0 0
Not Completed 0 0 0 0
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Period Title: Phase I: Dose Level 2
Started 0 7 0 0
Completed 0 6 [1] 0 0
Not Completed 0 1 0 0
Reason Not Completed
Protocol Violation             0             1             0             0
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Period Title: Phase II: Dose Level 2
Started 0 0 0 47
Completed 0 0 0 47 [1]
Not Completed 0 0 0 0
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title Phase I: Temozolomide 100 mg Phase I: Temozolomide 150 mg Phase II: Temozolomide 100 mg Total
Hide Arm/Group Description Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Total of all reporting groups
Overall Number of Baseline Participants 6 6 47 59
Hide Baseline Analysis Population Description
Eligible patients who started study treatment
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 47 participants 59 participants
57
(43 to 70)
62
(47 to 72)
57
(24 to 73)
57
(24 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 47 participants 59 participants
Female
4
  66.7%
2
  33.3%
24
  51.1%
30
  50.8%
Male
2
  33.3%
4
  66.7%
23
  48.9%
29
  49.2%
1.Primary Outcome
Title Number of Phase I Participants Experiencing Toxicity
Hide Description A dose limiting toxicity (DLT) is defined as any grade 3 or 4 non-hematological toxicity (other than grade 3 nausea/vomiting) or any hematological toxicity resulting in the discontinuation of temozolomide. Toxicity evaluation for this dose escalation includes all toxicities occurring prior to the start of radiation therapy. If the patient did not receive radiation therapy, then toxicity evaluation included all toxicities occurring through week 15. Any grade 5 toxicity would result in immediate suspension of accrual.
Time Frame From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not.
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Hide Analysis Population Description
Eligible patients on Phase I arms who started study treatment
Arm/Group Title Phase I: Temozolomide 100mg Phase I: Temozolomide150 mg
Hide Arm/Group Description:
Phase I: Temozolomide 100mg
Phase I: Temozolomide 150 mg
Overall Number of Participants Analyzed 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
3
  50.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase I: Temozolomide 100mg, Phase I: Temozolomide150 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis Dose escalation followed the standard 3+3 design, although up to six patients could be accrued per dose level before suspending accrual for toxicity evaluation. If none of the first three patients (0/3), or one of the first three and none of the second three (1/3 and 0/3), experience a DLT, then the current dose level would be considered acceptable, and the next dose opened. Otherwise, the current dose level would be considered too toxic. The highest dose achieved with an acceptable level of toxicity was to considered the Maximum Tolerable Dose (MTD). If at any time a grade 5 toxicity was observed, accrual will be suspended, and the Study Chair would review the event. Furthermore, if the cumulative incidence (obtained by time to event analysis), at any time, of combined acute/late DLTs estimated the toxicity rate to be greater than 30% at any dose level, then the Executive Committee will be notified, and the committee would determine whether to stop accrual.
2.Primary Outcome
Title Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)
Hide Description Survival time is defined as time from registration 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. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Time Frame Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients on Temozolomide 100 mg arms who started study treatment
Arm/Group Title Combined Temozolomide 100mg Arms
Hide Arm/Group Description:
Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80.8
(70.1 to 91.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Temozolomide 100mg Arms
Comments Null hypothesis: Two-year survival rate <= 64%; Alternative hypothesis: Two-year survival rate > 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method One-sample z-test
Comments [Not Specified]
3.Secondary Outcome
Title Phase II: Pre-irradiation Chemotherapy Tumor Response Rate (Including Phase I Patients at Same Dose)
Hide Description Tumor response was centrally reviewed. Complete response: Disappearance of all enhancing tumor, the patient must be off steroid therapy and neurologically stable or improved; partial response: ≥ 50% decrease in enhancing tumor; progressive disease: ≥ 25% increase in a lesion, progressive or newly emergent meningeal or ocular disease. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Time Frame From start of treatment to 10 weeks if RT received, to 15 weeks if not.
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Hide Analysis Population Description
Eligible patients on Temozolomide 100 mg arms who started study treatment and have scans for central review
Arm/Group Title Combined Temozolomide 100mg Arms
Hide Arm/Group Description:
Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
18
  51.4%
Partial Response
12
  34.3%
Progressive Disease
2
   5.7%
Not evaluable
3
   8.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Temozolomide 100mg Arms
Comments RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Chi-squared
Comments One-sample test of proportions
4.Secondary Outcome
Title Phase II: Progression-free Survival (Including Phase I Patients at Same Dose)
Hide Description Progression is defined as greater than 25% increase in enhancing tumor or the appearance of new lesions in the brain, eye, or the appearance of a new positive cerebrospinal fluid (CSF) cytology. The patient may be neurologically stable or worse and on stable or increasing doses of corticosteroid. 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. (Please note that this outcome measure is considered a secondary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Time Frame Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients on Temozolomide 100 mg arms who started study treatment
Arm/Group Title Combined Temozolomide 100mg Arms
Hide Arm/Group Description:
Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
Overall Number of Participants Analyzed 53
Median (95% Confidence Interval)
Unit of Measure: years
5.4
(1.8 to 7.3)
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Phase I: Temozolomide 100 mg Phase I: Temozolomide 150 mg Phase II: Temozolomide 100 mg
Hide Arm/Group Description Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Rituximab, methotrexate, temozolomide 150 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2. Rituximab, methotrexate, temozolomide 100 mg/m^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m^2.
All-Cause Mortality
Phase I: Temozolomide 100 mg Phase I: Temozolomide 150 mg Phase II: Temozolomide 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: Temozolomide 100 mg Phase I: Temozolomide 150 mg Phase II: Temozolomide 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/6 (50.00%)   4/6 (66.67%)   16/47 (34.04%) 
Blood and lymphatic system disorders       
Febrile neutropenia * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Hemoglobin decreased * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Gastrointestinal disorders       
Vomiting NOS * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
General disorders       
Fatigue * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Late RT Toxicity:Other NOS  2  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Pain-other * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Aspartate aminotransferase increased * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Leukopenia NOS * 1  2/6 (33.33%)  1/6 (16.67%)  5/47 (10.64%) 
Neutropenia * 1  3/6 (50.00%)  2/6 (33.33%)  5/47 (10.64%) 
Platelet count decreased * 1  1/6 (16.67%)  1/6 (16.67%)  7/47 (14.89%) 
Metabolism and nutrition disorders       
Alkalosis NOS * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Hyperglycemia NOS * 1  0/6 (0.00%)  0/6 (0.00%)  2/47 (4.26%) 
Nervous system disorders       
Ataxia NEC * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Convulsions NOS * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Encephalopathy NOS * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Headache NOS * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Learning disorder NOS * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Peripheral motor neuropathy * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Speech disorder NEC * 1  0/6 (0.00%)  0/6 (0.00%)  2/47 (4.26%) 
Renal and urinary disorders       
Renal failure NOS * 1  1/6 (16.67%)  0/6 (0.00%)  0/47 (0.00%) 
Vascular disorders       
Thrombosis NOS * 1  0/6 (0.00%)  0/6 (0.00%)  1/47 (2.13%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I: Temozolomide 100 mg Phase I: Temozolomide 150 mg Phase II: Temozolomide 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   6/6 (100.00%)   47/47 (100.00%) 
Blood and lymphatic system disorders       
Hematologic-Other * 1  0/6 (0.00%)  1/6 (16.67%)  2/47 (4.26%) 
Hemoglobin decreased * 1  5/6 (83.33%)  6/6 (100.00%)  39/47 (82.98%) 
Hemolysis NOS * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Platelet transfusion * 1  2/6 (33.33%)  0/6 (0.00%)  3/47 (6.38%) 
Cardiac disorders       
Arrhythmia NOS * 1  0/6 (0.00%)  1/6 (16.67%)  2/47 (4.26%) 
Edema NOS * 1  3/6 (50.00%)  2/6 (33.33%)  12/47 (25.53%) 
Endocrine disorders       
Cushingoid * 1  1/6 (16.67%)  0/6 (0.00%)  1/47 (2.13%) 
Eye disorders       
Cataract NEC * 1  1/6 (16.67%)  0/6 (0.00%)  1/47 (2.13%) 
Diplopia * 1  0/6 (0.00%)  1/6 (16.67%)  5/47 (10.64%) 
Dry eye NEC * 1  1/6 (16.67%)  0/6 (0.00%)  3/47 (6.38%) 
Late RT Toxicity:Eye NOS  2  2/6 (33.33%)  0/6 (0.00%)  5/47 (10.64%) 
Ocular-Other * 1  1/6 (16.67%)  0/6 (0.00%)  5/47 (10.64%) 
Vision blurred * 1  1/6 (16.67%)  1/6 (16.67%)  15/47 (31.91%) 
Gastrointestinal disorders       
Constipation * 1  3/6 (50.00%)  1/6 (16.67%)  11/47 (23.40%) 
Diarrhea NOS * 1  1/6 (16.67%)  2/6 (33.33%)  11/47 (23.40%) 
Esophageal spasm * 1  0/6 (0.00%)  1/6 (16.67%)  1/47 (2.13%) 
Esophagitis NOS * 1  1/6 (16.67%)  0/6 (0.00%)  7/47 (14.89%) 
Nausea * 1  5/6 (83.33%)  4/6 (66.67%)  32/47 (68.09%) 
Stomatitis * 1  2/6 (33.33%)  1/6 (16.67%)  11/47 (23.40%) 
Vomiting NOS * 1  5/6 (83.33%)  1/6 (16.67%)  25/47 (53.19%) 
General disorders       
Fatigue * 1  6/6 (100.00%)  6/6 (100.00%)  42/47 (89.36%) 
Late RT Toxicity:Other NOS  2  2/6 (33.33%)  1/6 (16.67%)  10/47 (21.28%) 
Pain-other * 1  0/6 (0.00%)  2/6 (33.33%)  16/47 (34.04%) 
Rigors * 1  1/6 (16.67%)  0/6 (0.00%)  5/47 (10.64%) 
Hepatobiliary disorders       
Hepatic-Other * 1  2/6 (33.33%)  1/6 (16.67%)  2/47 (4.26%) 
Immune system disorders       
Allergy-Other * 1  3/6 (50.00%)  0/6 (0.00%)  0/47 (0.00%) 
Infections and infestations       
Infection NOS * 1  2/6 (33.33%)  0/6 (0.00%)  9/47 (19.15%) 
Infection with grade 3 or 4 neutropenia * 1  0/6 (0.00%)  1/6 (16.67%)  5/47 (10.64%) 
Injury, poisoning and procedural complications       
Dermatitis radiation NOS * 1  3/6 (50.00%)  3/6 (50.00%)  17/47 (36.17%) 
Ecchymosis * 1  0/6 (0.00%)  1/6 (16.67%)  5/47 (10.64%) 
Late RT Toxicity:Skin(within RT field)NOS  2  3/6 (50.00%)  0/6 (0.00%)  9/47 (19.15%) 
Operative injury of vein/artery * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  5/6 (83.33%)  3/6 (50.00%)  27/47 (57.45%) 
Aspartate aminotransferase increased * 1  4/6 (66.67%)  2/6 (33.33%)  24/47 (51.06%) 
Blood alkaline phosphatase NOS increased * 1  2/6 (33.33%)  1/6 (16.67%)  6/47 (12.77%) 
Blood bilirubin increased * 1  0/6 (0.00%)  1/6 (16.67%)  6/47 (12.77%) 
Blood creatinine increased * 1  3/6 (50.00%)  1/6 (16.67%)  15/47 (31.91%) 
Gamma-glutamyltransferase increased * 1  1/6 (16.67%)  1/6 (16.67%)  1/47 (2.13%) 
Leukopenia NOS * 1  4/6 (66.67%)  5/6 (83.33%)  26/47 (55.32%) 
Lymphopenia * 1  1/6 (16.67%)  2/6 (33.33%)  20/47 (42.55%) 
Metabolic-Other * 1  1/6 (16.67%)  1/6 (16.67%)  5/47 (10.64%) 
Neutropenia * 1  2/6 (33.33%)  3/6 (50.00%)  19/47 (40.43%) 
Platelet count decreased * 1  4/6 (66.67%)  1/6 (16.67%)  30/47 (63.83%) 
Prothrombin time prolonged * 1  0/6 (0.00%)  1/6 (16.67%)  2/47 (4.26%) 
Weight decreased * 1  2/6 (33.33%)  3/6 (50.00%)  10/47 (21.28%) 
Weight increased * 1  1/6 (16.67%)  0/6 (0.00%)  6/47 (12.77%) 
Metabolism and nutrition disorders       
Anorexia * 1  3/6 (50.00%)  3/6 (50.00%)  17/47 (36.17%) 
Blood albumin decreased * 1  2/6 (33.33%)  0/6 (0.00%)  5/47 (10.64%) 
Blood bicarbonate decreased * 1  1/6 (16.67%)  0/6 (0.00%)  1/47 (2.13%) 
Blood magnesium decreased * 1  0/6 (0.00%)  2/6 (33.33%)  1/47 (2.13%) 
Dehydration * 1  1/6 (16.67%)  0/6 (0.00%)  5/47 (10.64%) 
Hyperglycemia NOS * 1  2/6 (33.33%)  2/6 (33.33%)  12/47 (25.53%) 
Hyperkalemia * 1  0/6 (0.00%)  1/6 (16.67%)  5/47 (10.64%) 
Hypernatremia * 1  1/6 (16.67%)  0/6 (0.00%)  4/47 (8.51%) 
Hyperuricemia * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Hypocalcemia * 1  5/6 (83.33%)  4/6 (66.67%)  26/47 (55.32%) 
Hypoglycaemia NOS * 1  0/6 (0.00%)  1/6 (16.67%)  4/47 (8.51%) 
Hypokalemia * 1  1/6 (16.67%)  1/6 (16.67%)  14/47 (29.79%) 
Hyponatremia * 1  1/6 (16.67%)  1/6 (16.67%)  8/47 (17.02%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/6 (16.67%)  1/6 (16.67%)  6/47 (12.77%) 
Bone pain * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Joint, muscle, or bone-Other * 1  0/6 (0.00%)  1/6 (16.67%)  3/47 (6.38%) 
Muscle weakness NOS * 1  2/6 (33.33%)  1/6 (16.67%)  10/47 (21.28%) 
Nervous system disorders       
Amnesia NEC * 1  2/6 (33.33%)  2/6 (33.33%)  14/47 (29.79%) 
Ataxia NEC * 1  2/6 (33.33%)  2/6 (33.33%)  13/47 (27.66%) 
Cerebral ischaemia * 1  1/6 (16.67%)  0/6 (0.00%)  0/47 (0.00%) 
Convulsions NOS * 1  0/6 (0.00%)  1/6 (16.67%)  5/47 (10.64%) 
Dizziness (exc vertigo) * 1  0/6 (0.00%)  1/6 (16.67%)  7/47 (14.89%) 
Headache NOS * 1  4/6 (66.67%)  2/6 (33.33%)  30/47 (63.83%) 
Late RT Toxicity:Brain NOS  2  2/6 (33.33%)  1/6 (16.67%)  5/47 (10.64%) 
Late RT Toxicity:Encephalopathy NOS  2  0/6 (0.00%)  1/6 (16.67%)  2/47 (4.26%) 
Neuralgia NOS * 1  0/6 (0.00%)  1/6 (16.67%)  7/47 (14.89%) 
Neurologic-Other * 1  1/6 (16.67%)  1/6 (16.67%)  3/47 (6.38%) 
Peripheral motor neuropathy * 1  3/6 (50.00%)  3/6 (50.00%)  15/47 (31.91%) 
Peripheral sensory neuropathy * 1  3/6 (50.00%)  2/6 (33.33%)  10/47 (21.28%) 
Speech disorder NEC * 1  3/6 (50.00%)  0/6 (0.00%)  6/47 (12.77%) 
Taste disturbance * 1  3/6 (50.00%)  0/6 (0.00%)  14/47 (29.79%) 
Tremor NEC * 1  1/6 (16.67%)  0/6 (0.00%)  0/47 (0.00%) 
Psychiatric disorders       
Anxiety NEC * 1  1/6 (16.67%)  1/6 (16.67%)  9/47 (19.15%) 
Confusion * 1  0/6 (0.00%)  1/6 (16.67%)  9/47 (19.15%) 
Depression NEC * 1  2/6 (33.33%)  2/6 (33.33%)  9/47 (19.15%) 
Insomnia NEC * 1  2/6 (33.33%)  0/6 (0.00%)  10/47 (21.28%) 
Renal and urinary disorders       
Renal/GU-Other * 1  1/6 (16.67%)  1/6 (16.67%)  1/47 (2.13%) 
Urinary incontinence * 1  2/6 (33.33%)  1/6 (16.67%)  5/47 (10.64%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/6 (16.67%)  0/6 (0.00%)  6/47 (12.77%) 
Dysphonia * 1  1/6 (16.67%)  0/6 (0.00%)  0/47 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  4/6 (66.67%)  2/6 (33.33%)  24/47 (51.06%) 
Dermatitis exfoliative NOS * 1  1/6 (16.67%)  1/6 (16.67%)  11/47 (23.40%) 
Erythema multiforme * 1  0/6 (0.00%)  1/6 (16.67%)  0/47 (0.00%) 
Petechiae * 1  0/6 (0.00%)  1/6 (16.67%)  1/47 (2.13%) 
Pruritus NOS * 1  1/6 (16.67%)  1/6 (16.67%)  0/47 (0.00%) 
Skin-Other * 1  1/6 (16.67%)  0/6 (0.00%)  2/47 (4.26%) 
Vascular disorders       
Hypertension NOS * 1  3/6 (50.00%)  0/6 (0.00%)  6/47 (12.77%) 
Thrombosis NOS * 1  1/6 (16.67%)  0/6 (0.00%)  5/47 (10.64%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
The 200 mg/m^2 treatment arm in the phase I component of the study did not open. Outcome measures are categorized as the phase I or phase II study component, but phase I patients at corresponding dose level are included in the phase II analyses.
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: NCT00068250     History of Changes
Other Study ID Numbers: RTOG-0227
CDR0000301563
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: December 14, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018