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Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas

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ClinicalTrials.gov Identifier: NCT00100802
Recruitment Status : Completed
First Posted : January 7, 2005
Results First Posted : January 13, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain Tumors
Central Nervous System Tumors
Interventions Drug: lomustine
Drug: temozolomide
Procedure: adjuvant therapy
Radiation: radiation therapy
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up
Hide Arm/Group Description

Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.

lomustine: Capsule

temozolomide: Capsule

adjuvant therapy

radiation therapy

Period Title: Overall Study
Started 118
Completed 38
Not Completed 80
Reason Not Completed
Adverse Event             9
Death             1
Lack of Efficacy             47
Physician Decision             5
Protocol Violation             1
Withdrawal by Subject             5
Ineligible             12
Arm/Group Title Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Hide Arm/Group Description

Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.

lomustine: Capsule

temozolomide: Capsule

adjuvant therapy

radiation therapy

Overall Number of Baseline Participants 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
<=18 years
110
  93.2%
Between 18 and 65 years
8
   6.8%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 118 participants
12
(3 to 21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants
Female
55
  46.6%
Male
63
  53.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 118 participants
Canada 15
New Zealand 1
United States 98
Australia 4
1.Primary Outcome
Title One Year Overall Survival
Hide Description Estimated one year survival using the Kaplan-Meier methodology.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Population is based on 106 eligible patients out of 118 patients enrolled.
Arm/Group Title Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Hide Arm/Group Description:

Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.

lomustine: Capsule

temozolomide: Capsule

adjuvant therapy

radiation therapy

Overall Number of Participants Analyzed 106
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated probability
0.7208
(0.6237 to 0.7968)
2.Primary Outcome
Title Occurrence of Death Attributable to Complications of Protocol Therapy
Hide Description Number of deaths due to complications of protocol therapy.
Time Frame While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy
Hide Outcome Measure Data
Hide Analysis Population Description
106 eligible patients out of 118 patients enrolled is the population basis for this outcome measure.
Arm/Group Title Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Hide Arm/Group Description:

Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.

lomustine: Capsule

temozolomide: Capsule

adjuvant therapy

radiation therapy

Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: patients
1
Time Frame [Not Specified]
Adverse Event Reporting Description Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
 
Arm/Group Title Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Hide Arm/Group Description

Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.

lomustine: Capsule

temozolomide: Capsule

adjuvant therapy

radiation therapy

All-Cause Mortality
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Affected / at Risk (%) # Events
Total   3/106 (2.83%)    
Investigations   
Neutrophil count decreased  1/106 (0.94%)  1
White blood cell decreased  1/106 (0.94%)  1
Metabolism and nutrition disorders   
Anorexia  1/106 (0.94%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Affected / at Risk (%) # Events
Total   83/106 (78.30%)    
Blood and lymphatic system disorders   
Anemia  26/106 (24.53%)  26
Febrile neutropenia  5/106 (4.72%)  5
Hemolysis  1/106 (0.94%)  1
Endocrine disorders   
Cushingoid  1/106 (0.94%)  1
Endocrine disorders - Other, specify  1/106 (0.94%)  1
Eye disorders   
Extraocular muscle paresis  1/106 (0.94%)  1
Eye disorders - Other, specify  1/106 (0.94%)  1
Papilledema  1/106 (0.94%)  1
Gastrointestinal disorders   
Abdominal pain  1/106 (0.94%)  1
Constipation  1/106 (0.94%)  1
Diarrhea  1/106 (0.94%)  1
Dysphagia  2/106 (1.89%)  2
Intra-abdominal hemorrhage  1/106 (0.94%)  1
Nausea  10/106 (9.43%)  10
Oral pain  1/106 (0.94%)  1
Vomiting  10/106 (9.43%)  10
General disorders   
Edema limbs  1/106 (0.94%)  1
Fatigue  6/106 (5.66%)  6
Fever  1/106 (0.94%)  1
Gait disturbance  1/106 (0.94%)  1
Immune system disorders   
Allergic reaction  2/106 (1.89%)  2
Infections and infestations   
Anorectal infection  1/106 (0.94%)  1
Appendicitis  1/106 (0.94%)  1
Catheter related infection  1/106 (0.94%)  1
Gum infection  1/106 (0.94%)  1
Infections and infestations - Other, specify  5/106 (4.72%)  5
Meningitis  1/106 (0.94%)  1
Skin infection  2/106 (1.89%)  2
Upper respiratory infection  1/106 (0.94%)  1
Urinary tract infection  2/106 (1.89%)  2
Injury, poisoning and procedural complications   
Burn  1/106 (0.94%)  1
Radiation recall reaction (dermatologic)  1/106 (0.94%)  1
Investigations   
Alanine aminotransferase increased  4/106 (3.77%)  4
Alkaline phosphatase increased  1/106 (0.94%)  1
Aspartate aminotransferase increased  3/106 (2.83%)  3
Blood bilirubin increased  4/106 (3.77%)  4
GGT increased  2/106 (1.89%)  2
Investigations - Other, specify  1/106 (0.94%)  1
Lymphocyte count decreased  36/106 (33.96%)  36
Neutrophil count decreased  59/106 (55.66%)  59
Platelet count decreased  56/106 (52.83%)  56
Weight loss  1/106 (0.94%)  1
White blood cell decreased  48/106 (45.28%)  48
Metabolism and nutrition disorders   
Anorexia  1/106 (0.94%)  1
Dehydration  2/106 (1.89%)  2
Glucose intolerance  1/106 (0.94%)  1
Hyperglycemia  1/106 (0.94%)  1
Hypoalbuminemia  1/106 (0.94%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  2/106 (1.89%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1/106 (0.94%)  1
Nervous system disorders   
Abducens nerve disorder  1/106 (0.94%)  1
Ataxia  1/106 (0.94%)  1
Depressed level of consciousness  7/106 (6.60%)  7
Dysphasia  3/106 (2.83%)  3
Headache  5/106 (4.72%)  5
Hydrocephalus  3/106 (2.83%)  3
IVth nerve disorder  1/106 (0.94%)  1
Memory impairment  3/106 (2.83%)  3
Nervous system disorders - Other, specify  3/106 (2.83%)  3
Oculomotor nerve disorder  1/106 (0.94%)  1
Peripheral motor neuropathy  5/106 (4.72%)  5
Peripheral sensory neuropathy  3/106 (2.83%)  3
Seizure  8/106 (7.55%)  8
Syncope  1/106 (0.94%)  1
Psychiatric disorders   
Depression  2/106 (1.89%)  2
Personality change  1/106 (0.94%)  1
Psychosis  1/106 (0.94%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1/106 (0.94%)  1
Hypoxia  2/106 (1.89%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1/106 (0.94%)  1
Erythema multiforme  1/106 (0.94%)  1
Rash maculo-papular  3/106 (2.83%)  3
Vascular disorders   
Thromboembolic event  2/106 (1.89%)  2
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.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreporingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00100802     History of Changes
Other Study ID Numbers: ACNS0423
CDR0000407744 ( Other Identifier: Clinical Trials.gov )
COG-ACNS0423 ( Other Identifier: Children's Oncology Group )
NCI-2012-02645 ( Other Identifier: Registry ID: CTRP (Clinical Trial Reporting Program) )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: January 6, 2005
First Posted: January 7, 2005
Results First Submitted: November 18, 2016
Results First Posted: January 13, 2017
Last Update Posted: August 7, 2019