Phase III Trial of Anaplastic Glioma Without 1p/19q Loss... | NCT00626990

NCT00626990

ID	Type	Description
NCIC CTG CEC.1	Other Identifier	NCI-C
RTOG-0834	Other Identifier	RTOG
2006-001533-17	EudraCT Number
P04839	Other Grant/Funding Number	Merck
MRC BR14	Other Identifier	MRC CTU

Status Module

Name	Class
NCIC Clinical Trials Group	NETWORK
Radiation Therapy Oncology Group	NETWORK
Medical Research Council	OTHER_GOV
Merck Sharp & Dohme LLC

Description Module

Detailed Description

OBJECTIVES:

Primary

To assess whether concurrent radiotherapy with daily temozolomide improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma.
To assess whether adjuvant temozolomide improves survival as compared to no adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma.

Secondary

To assess whether concurrent and adjuvant temozolomide prolongs progression-free survival and neurological deterioration-free survival in patients with non-1p/19q deleted anaplastic glioma.
To assess the safety of concurrent and adjuvant temozolomide in patients with non-1p/19q deleted anaplastic glioma, including late effects on cognition.
To assess the impact of concurrent and adjuvant temozolomide on the quality of life of patients with non-1p/19q deleted anaplastic glioma.

OUTLINE: This is a multicenter study. Patients are stratified according to institution, World Health Organization (WHO) performance status (0 vs > 0), age (≤ 50 vs > 50), presence of 1p LOH only (yes vs no), presence of oligodendroglial elements (yes vs no), and O6-methylguanine-DNA methyltransferase promoter methylation status (methylated vs unmethylated vs indeterminate). Patients are randomized to 1 of 4 treatment arms.

Arm I: Patients undergo radiotherapy* once daily, 5 days a week, for 6.5 weeks (total of 33 fractions).
Arm II: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy).
Arm III: Patients undergo radiotherapy* once daily, 5 days a week for 6.5 weeks (total of 33 fractions). Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses.
Arm IV: Patients undergo radiotherapy* once daily, 5 days a week and receive oral temozolomide once daily for 6.5 weeks (total of 33 fractions of radiotherapy). Beginning 4 weeks after completion of radiotherapy, patients receive adjuvant oral temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 28 days for up to 12 courses.
Patients must begin radiotherapy within 8 days after randomization and within 7 weeks after surgery.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires, including EORTC core quality of life questionnaire (QLQ-C30) version 3, EORTC brain cancer module (BCM20), and the Mini Mental Status Exam at baseline, 4 weeks after the completion of radiotherapy, and then every 3 months for 5 years.

Tissue samples are collected at baseline for histology review, 1p/19q analysis, methylation status of the O6-methylguanine-DNA methyltransferase promoter, and isocitrate dehydrogenase mutation analysis.

After completion of study treatment, patients are followed every 3 months.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiotherapy (RT) alone	Active Comparator	radiation therapy alone	Genetic: DNA methylation analysis Other: laboratory biomarker analysis Procedure: quality-of-life assessment Radiation: radiation therapy
RT & Concurrent CT	Active Comparator	Radiotherapy and concurrent temozolomide chemotherapy	Drug: temozolomide Genetic: DNA methylation analysis Other: laboratory biomarker analysis Procedure: quality-of-life assessment Radiation: radiation therapy
RT + Adjuvant CT	Active Comparator	Radiotherapy plus adjuvant temozolomide chemotherapy	Drug: temozolomide Genetic: DNA methylation analysis Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy
RT & Concurrent CT + adjuvant CT	Active Comparator	Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy	Drug: temozolomide Genetic: DNA methylation analysis Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: quality-of-life assessment Radiation: radiation therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
temozolomide	Drug	Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy.	RT & Concurrent CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival as Measured From the Day of Randomization	The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.	from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival	Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms.

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of 1 of the following:
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- Anaplastic astrocytoma
Newly diagnosed disease
Prior surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
Absence of combined 1p/19q loss
Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review
Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9 cells/L
Platelet count ≥ 100 x 10^9 cells/L
Bilirubin < 1.5 x upper limit of normal (ULN)
Alkaline phosphatase < 2.5 x ULN
Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2.5 x ULN
Serum creatinine < 1.5 x ULN
Not pregnant or nursing
Fertile patients must use effective contraception
No known HIV infection or chronic hepatitis B or hepatitis C infection
No other serious medical condition that would interfere with follow-up
No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
No other prior malignancies except for any malignancy which was treated with curative intent more than 5 years prior to registration and adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
No prior or concurrent malignancies at other sites except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
No psychological, familial, sociological, or geographical condition that would potentially hamper compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
No prior radiotherapy to the brain
No concurrent growth factors unless vital for the patient
No other concurrent investigational treatment
No other concurrent anticancer agents

Name	Affiliation	Role
Wolfgang Wick	UNIVERSITATSKLINIKUM HEIDELBERG	Study Chair
Warren P. Mason, MD	Princess Margaret Hospital, Canada	Study Chair
Michael A. Vogelbaum, MD, PhD	The Cleveland Clinic	Study Chair
S. Erridge	Medical Research Council	Study Chair
Anna Nowak, MD	Sir Charles Gairdner Hospital - Nedlands	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Oncology Services Foundation		Phoenix	Arizona		United States
Cedars-Sinai Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41449147	Derived	van den Bent MJ, Ghisai SA, Wick W, Sanson M, Brandes AA, Clement PM, Erridge SC, Vogelbaum MA, Nowak AK, Baurain JF, Mason WP, Wheeler H, Tabouret E, Gill S, Griffin M, Taal W, Ruda R, Weller M, McBain C, Reijneveld JC, Enting RH, Tran S, Lesimple T, Kocher M, Gijtenbeek A, Lim E, Herrlinger U, Hau P, Dhermain F, Aldape K, Jenkins RB, Dubbink HJ, Kros JM, Wesseling P, Hoogstrate Y, Nuyens S, Golfinopoulos V, Tesileanu CMS, Gorlia T, French P, Baumert BG. Concurrent and adjuvant temozolomide for 1p/19q non-co-deleted anaplastic glioma (CATNON; EORTC study 26053-22054): final and exploratory analyses of a randomised, open-label, phase 3 trial. Lancet Oncol. 2026 Jan;27(1):45-56. doi: 10.1016/S1470-2045(25)00614-X.
35275197

Label	URL
Clinical trial summary from the EORTC database	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	RT Alone	radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 7, 2020

Arm/Group Information

ID	Title	Description
BG000	RT Alone	radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
BG001	RT & Concurrent CT	Radiotherapy and concurrent temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
BG002	RT + Adjuvant CT	Radiotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
BG003	RT & Concurrent CT + Adjuvant CT	Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002186 ParticipantsBG003

Age, Continuous

Median

Full Range

years

Title	Denominators	Categories
	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
Canada	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002

Presence of oligodendroglial elements

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002

World Health Organization (WHO) Performance Status

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002

Procedure for pathology and genetic testing

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002

Presence of 1p LOH

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002

MGMT Methylation status

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000189 ParticipantsBG001188 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Overall Survival as Measured From the Day of Randomization

The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.

This trial studied 2 questions 1) effect of concomitant Temozolomide (TMZ) 2) effect of adjuvant TMZ. The 4 randomized arms were combined. Absence of concomitant TMZ including Arm Radiotherapy (RT) alone & Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT & Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone & Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ & Arm TMZ/RT followed by adjuvant TMZ

Posted

Median

95% Confidence Interval

Months

from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)

ID	Title	Description
OG000	Absence of Concomitant Temozolomide (TMZ)	Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ
OG001	Presence of Concomitant Temozolomide (TMZ)	Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ
OG002	Absence of Adjuvant Temozolomide (TMZ)	Including two randomized arms: Arm RT alone and Arm TMZ/RT
OG003	Presence of Adjuvant Temozolomide (TMZ)	Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ

Units	Counts
Participants	OG000375 OG001376 OG002377 OG003

Title

Denominators

Categories

Title	Measurements
	OG00060.42(45.7 to 71.49) OG00166.92(48.53 to 82.33) OG00246.92(37.88 to 56.94) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		0.76		Hazard Ratio (HR)	0.97			2-Sided	99.1	0.73	1.28					Superiority
OG002 OG003		Regression, Cox		<0.0001

Secondary

Progression-free Survival

Disease progression is defined as radiological or neurological/clinical progression (whichever occurs first); progression free survival (PFS) is the time interval between the date of randomization and the date of disease progression or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination. Radiological progression was defined as increase of contrast enhancing area on MRI or CT scans of more than 25% as measured by two perpendicular diameters compared to the smallest measurements ever recorded for the same lesion by the same technique. The appearance of new lesions with or without contrast enhancement Neurological/clinical progression was defined as:decrease in WHO performance status,deterioration of neurological functions,appearance of signs/symptoms of increased intracranial pressure,and/or start of corticosteroid or increase of corticosteroid dosage by 50% for control of neurological symptoms.

This trial studied separately two questions 1) effect of concomitant TMZ 2) effect of adjuvant TMZ. The 4 randomized arms were combined before analysis. Absence of concomitant TMZ including Arm RT alone & Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT & Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone & Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ & Arm TMZ/RT followed by adjuvant TMZ

Posted

Median

95% Confidence Interval

Months

from randomization till the date of disease progression or death (time till death is up to 10.9 years after patient enrollment in the study)

ID	Title	Description
OG000	Absence of Concomitant TMZ

Secondary

Quality of Life of the Patient

Quality of life was assessed by the EORTC Quality of Life Questionnaire (QLQ-C30) version 3 and the Brain Cancer Module-20

Not Posted

Apr 2025

from 14 days prior to randomization till five years or death (time till death is up to 10.9 years after patient enrollment in the study)

Participants

Secondary

Neurological Deterioration Free Survival

Neurological deterioration is defined as a decrease in WHO performance status as follows:

decrease in WHO performance status

for patients with baseline WHO performance status 0: deterioration to WHO performance status 2 or worse for which no other explanation is present, and which is maintained for at least three months
for patients with baseline WHO performance status 1 or 2: deterioration to WHO performance status 3 or worse for which no other explanation is present and which is maintained for at least three months

The date of neurological deterioration will be the first date the persistent decrease in performance status was diagnosed. Neurological deterioration free progression is the time interval between the date of randomization and the date of neurological deterioration or death whichever occurs first. If neither event has been observed, the patient is censored at the date of the last follow up examination

Not Posted

within 2 weeks of randomization; during radiotherapy at week 4 and 6; 4 weeks after the end of radiotherapy; Six monthly after the end of radiotherapy; Prior to each cycle of adjuvant therapy; Every six months after the documentation of first progression.

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RT Alone	radiation therapy alone DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	107	189	13	186	182	186
EG001	RT & Concurrent CT	Radiotherapy and concurrent temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	97	188	27	185	183	185
EG002	RT + Adjuvant CT	Radiotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	78	186	32	183	182	183
EG003	RT & Concurrent CT + Adjuvant CT	Radiotherapy and concurrent chemotherapy plus adjuvant temozolomide chemotherapy temozolomide: Patients randomized to concomitant temozolomide will receive temozolomide continuously at a daily dose of 75 mg/m² during radiotherapy. DNA methylation analysis: MGMT methylation status is used for stratification at randomization. laboratory biomarker analysis: Prognostic factor analyses adjuvant therapy: Patients randomized to adjuvant temozolomide will start adjuvant temozolomide after a 4 week resting period after the end of radiotherapy. quality-of-life assessment: Quality of Life analysis will also be used to assess neurological deterioration free progression radiation therapy: Radiotherapy will consist of a conventionally fractionated regimen for 6.5 weeks in a once daily schedule	74	188	32	185	185	185

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
VASCULAR	Vascular disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0011 affected185 at risk EG0021 affected183 at risk EG0030 affected185 at risk
ALLERGY/IMMUNOLOGY	Immune system disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0010 affected185 at risk EG0022 affected183 at risk EG003
CONSTITUTIONAL SYMPTOMS	General disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0017 affected185 at risk EG0022 affected183 at risk EG003
PAIN	General disorders	CTCAE (3.0)	Systematic Assessment	EG0002 affected186 at risk EG0012 affected185 at risk EG0024 affected183 at risk EG003
CARDIAC(GENERAL)	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected186 at risk EG0010 affected185 at risk EG0020 affected183 at risk EG003
BLOOD	Blood and lymphatic system disorders	CTCAE (3.0)	Systematic Assessment	EG0002 affected186 at risk EG0012 affected185 at risk EG0022 affected183 at risk EG003
LYMPHATICS	Blood and lymphatic system disorders	CTCAE (3.0)	Systematic Assessment	EG0002 affected186 at risk EG0010 affected185 at risk EG0021 affected183 at risk EG003
PULMONARY/UPPER RESPIRATORY	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0010 affected185 at risk EG0020 affected183 at risk EG003
NEUROLOGY	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG0009 affected186 at risk EG00115 affected185 at risk EG00212 affected183 at risk EG003
OCULAR/VISUAL	Eye disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0012 affected185 at risk EG0020 affected183 at risk EG003
GASTROINTESTINAL	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected186 at risk EG0012 affected185 at risk EG0024 affected183 at risk EG003
RENAL/GENITOURINARY	Renal and urinary disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0010 affected185 at risk EG0021 affected183 at risk EG003
DERMATOLOGY/SKIN	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected186 at risk EG0012 affected185 at risk EG0020 affected183 at risk EG003
MUSCULOSKELETAL/SOFT TISSUE	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0010 affected185 at risk EG0021 affected183 at risk EG003
METABOLIC/LABORATORY	Metabolism and nutrition disorders	CTCAE (3.0)	Systematic Assessment	EG0001 affected186 at risk EG0012 affected185 at risk EG0021 affected183 at risk EG003
INFECTION	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG0006 affected186 at risk EG0014 affected185 at risk EG0028 affected183 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
VASCULAR	Vascular disorders	CTCAE (3.0)	Systematic Assessment	EG0002 affected186 at risk EG0017 affected185 at risk EG0025 affected183 at risk EG0037 affected185 at risk
SURGERY/INTRA-OPERATIVE INJURY	Surgical and medical procedures	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0010 affected185 at risk EG0020 affected183 at risk EG003
ALLERGY/IMMUNOLOGY	Immune system disorders	CTCAE (3.0)	Systematic Assessment	EG0007 affected186 at risk EG0019 affected185 at risk EG00211 affected183 at risk EG003
CONSTITUTIONAL SYMPTOMS	General disorders	CTCAE (3.0)	Systematic Assessment	EG000151 affected186 at risk EG001160 affected185 at risk EG002170 affected183 at risk EG003
PAIN	General disorders	CTCAE (3.0)	Systematic Assessment	EG000129 affected186 at risk EG001131 affected185 at risk EG002138 affected183 at risk EG003
SEXUAL/REPRODUCTIVE FUNCTION	Reproductive system and breast disorders	CTCAE (3.0)	Systematic Assessment	EG0002 affected186 at risk EG0014 affected185 at risk EG0027 affected183 at risk EG003
CARDIAC(GENERAL)	Cardiac disorders	CTCAE (3.0)	Systematic Assessment	EG0009 affected186 at risk EG00115 affected185 at risk EG00217 affected183 at risk EG003
PULMONARY/UPPER RESPIRATORY	Respiratory, thoracic and mediastinal disorders	CTCAE (3.0)	Systematic Assessment	EG0008 affected186 at risk EG0019 affected185 at risk EG00217 affected183 at risk EG003
BLOOD	Blood and lymphatic system disorders	CTCAE (3.0)	Systematic Assessment	EG0005 affected186 at risk EG00112 affected185 at risk EG00210 affected183 at risk EG003
LYMPHATICS	Blood and lymphatic system disorders	CTCAE (3.0)	Systematic Assessment	EG00012 affected186 at risk EG00110 affected185 at risk EG00214 affected183 at risk EG003
NEUROLOGY	Nervous system disorders	CTCAE (3.0)	Systematic Assessment	EG000147 affected186 at risk EG001153 affected185 at risk EG002148 affected183 at risk EG003
OCULAR/VISUAL	Eye disorders	CTCAE (3.0)	Systematic Assessment	EG00051 affected186 at risk EG00162 affected185 at risk EG00248 affected183 at risk EG003
AUDITORY/EAR	Ear and labyrinth disorders	CTCAE (3.0)	Systematic Assessment	EG00030 affected186 at risk EG00123 affected185 at risk EG00233 affected183 at risk EG003
GASTROINTESTINAL	Gastrointestinal disorders	CTCAE (3.0)	Systematic Assessment	EG000107 affected186 at risk EG001136 affected185 at risk EG002158 affected183 at risk EG003
RENAL/GENITOURINARY	Renal and urinary disorders	CTCAE (3.0)	Systematic Assessment	EG00011 affected186 at risk EG0017 affected185 at risk EG00216 affected183 at risk EG003
HEPATOBILIAR/PANCREAS	Hepatobiliary disorders	CTCAE (3.0)	Systematic Assessment	EG0000 affected186 at risk EG0010 affected185 at risk EG0020 affected183 at risk EG003
DERMATOLOGY/SKIN	Skin and subcutaneous tissue disorders	CTCAE (3.0)	Systematic Assessment	EG000146 affected186 at risk EG001139 affected185 at risk EG002147 affected183 at risk EG003
MUSCULOSKELETAL/SOFT TISSUE	Musculoskeletal and connective tissue disorders	CTCAE (3.0)	Systematic Assessment	EG00016 affected186 at risk EG00117 affected185 at risk EG00223 affected183 at risk EG003
ENDOCRINE	Endocrine disorders	CTCAE (3.0)	Systematic Assessment	EG0006 affected186 at risk EG0018 affected185 at risk EG0029 affected183 at risk EG003
METABOLIC/LABORATORY	Metabolism and nutrition disorders	CTCAE (3.0)	Systematic Assessment	EG0007 affected186 at risk EG0017 affected185 at risk EG0028 affected183 at risk EG003
INFECTION	Infections and infestations	CTCAE (3.0)	Systematic Assessment	EG00037 affected186 at risk EG00135 affected185 at risk EG00272 affected183 at risk EG003

ID	Term
D016543	Central Nervous System Neoplasms
D009837	Oligodendroglioma
D001254	Astrocytoma

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009422	Nervous System Diseases
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue

ID	Term
D000077204	Temozolomide
D019175	DNA Methylation
D017024	Chemotherapy, Adjuvant
D011878	Radiotherapy

ID	Term
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D008745	Methylation
D000478	Alkylation
D001669	Biochemical Phenomena
D055598	Chemical Phenomena
D008660	Metabolism
D055614	Genetic Phenomena
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy