Trial Outcomes & Findings for Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas (NCT NCT00100802)
NCT ID: NCT00100802
Last Updated: 2023-02-15
Results Overview
Estimated one year survival using the Kaplan-Meier methodology.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
One year
Results posted on
2023-02-15
Participant Flow
Participant milestones
| Measure |
Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up
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 Study
STARTED
|
118
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
| Measure |
Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up
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 Study
Adverse Event
|
9
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
47
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Ineligible
|
12
|
Baseline Characteristics
Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Baseline characteristics by cohort
| Measure |
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
n=118 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
110 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: Population is based on 106 eligible patients out of 118 patients enrolled.
Estimated one year survival using the Kaplan-Meier methodology.
Outcome measures
| Measure |
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
n=106 Participants
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
|
|---|---|
|
One Year Overall Survival
|
0.7208 Estimated probability
Interval 0.6237 to 0.7968
|
PRIMARY outcome
Timeframe: While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol TherapyPopulation: 106 eligible patients out of 118 patients enrolled is the population basis for this outcome measure.
Number of deaths due to complications of protocol therapy.
Outcome measures
| Measure |
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
n=106 Participants
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
|
|---|---|
|
Occurrence of Death Attributable to Complications of Protocol Therapy
|
1 patients
|
Adverse Events
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
Serious events: 3 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
n=106 participants at risk
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
|
|---|---|
|
Investigations
Neutrophil count decreased
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
White blood cell decreased
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Metabolism and nutrition disorders
Anorexia
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
Other adverse events
| Measure |
Surgery, Chemoradiotherapy, Rest, Maintenance, FUP
n=106 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
24.5%
26/106 • Number of events 26
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.7%
5/106 • Number of events 5
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Endocrine disorders
Cushingoid
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Eye disorders
Extraocular muscle paresis
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Eye disorders
Eye disorders - Other, specify
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Eye disorders
Papilledema
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Gastrointestinal disorders
Abdominal pain
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Gastrointestinal disorders
Constipation
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Gastrointestinal disorders
Diarrhea
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Gastrointestinal disorders
Nausea
|
9.4%
10/106 • Number of events 10
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Gastrointestinal disorders
Oral pain
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
10/106 • Number of events 10
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
General disorders
Edema limbs
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
General disorders
Fatigue
|
5.7%
6/106 • Number of events 6
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
General disorders
Fever
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
General disorders
Gait disturbance
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Immune system disorders
Allergic reaction
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Anorectal infection
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Appendicitis
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Catheter related infection
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Gum infection
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.7%
5/106 • Number of events 5
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Meningitis
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Skin infection
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Upper respiratory infection
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Injury, poisoning and procedural complications
Burn
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
4/106 • Number of events 4
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Alkaline phosphatase increased
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
3/106 • Number of events 3
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Blood bilirubin increased
|
3.8%
4/106 • Number of events 4
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
GGT increased
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Investigations - Other, specify
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Lymphocyte count decreased
|
34.0%
36/106 • Number of events 36
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Neutrophil count decreased
|
55.7%
59/106 • Number of events 59
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Platelet count decreased
|
52.8%
56/106 • Number of events 56
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
Weight loss
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Investigations
White blood cell decreased
|
45.3%
48/106 • Number of events 48
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Metabolism and nutrition disorders
Anorexia
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Abducens nerve disorder
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Ataxia
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Depressed level of consciousness
|
6.6%
7/106 • Number of events 7
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Dysphasia
|
2.8%
3/106 • Number of events 3
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Headache
|
4.7%
5/106 • Number of events 5
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Hydrocephalus
|
2.8%
3/106 • Number of events 3
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
IVth nerve disorder
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Memory impairment
|
2.8%
3/106 • Number of events 3
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.8%
3/106 • Number of events 3
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Oculomotor nerve disorder
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.7%
5/106 • Number of events 5
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.8%
3/106 • Number of events 3
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Seizure
|
7.5%
8/106 • Number of events 8
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Nervous system disorders
Syncope
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Psychiatric disorders
Depression
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Psychiatric disorders
Personality change
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Psychiatric disorders
Psychosis
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.94%
1/106 • Number of events 1
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.8%
3/106 • Number of events 3
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
|
Vascular disorders
Thromboembolic event
|
1.9%
2/106 • Number of events 2
Serious adverse events, only eligible patients are considered. Other adverse events, only eligible patients are considered
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 626-447-0064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER