Radiation Therapy in Treating Young Patients With Gliomas

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00238264
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 92
• Locations: 145
• Arm: 1
• Duration (Months): 146
• Patients Per Site: 0.6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating young patients with gliomas.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor; Central Nervous System Tumor	Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the marginal-failure rate in young patients with low-grade gliomas treated with reduced-field conformal radiotherapy.

Secondary

• Determine the progression-free survival, event-free survival, and overall survival rates of young patients treated with this regimen.

• Determine quality of life of patients treated with this regimen.

• Correlate MIB-1 labeling index with progression-free survival and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients undergo reduced-field conformal radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline or 6 weeks after completion of study treatment and then at 2 and 5 years (closed as of 10/27/2010).

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Dec 30, 2013
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (radiotherapy) Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.	Radiation: radiation therapy; Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT; Other Names: 3-dimensional conformal radiation therapy intensity-modulated radiation therapy 3D conformal radiation therapy 3D-CRT IMRT

Outcome Measures

Primary Outcome Measures

1. Marginal-failure Rate [Up to 5 years]

   Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.

Secondary Outcome Measures

1. Progression-free Survival Probability [3 years]

   To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.

2. Event-free Survival Probability [3 years]

   To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation

3. Overall Survival Probability [3 years]

   To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.

4. Quality of Life (QOL) [Up to 5 years]

   QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).

5. MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods [At baseline]

   The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.

6. Correlation MIB-1 Labeling Index With PFS [Up to 10 years]

   The primary methods of analysis will be via stratified Cox regression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed* low-grade glioma, including any of the following:

• Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA

• Diffuse astrocytoma, including any of the following subtypes:

• Fibrillary astrocytoma

• Gemistocytic astrocytoma

• Subependymal giant cell astrocytoma

• Pleomorphic xanthoastrocytoma

• Low-grade oligoastrocytoma

• Low-grade oligodendroglioma

• Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions who have contiguous extension of tumor into other regions of the visual pathway by CT scan or MRI are eligible without histopathologic confirmation; repeat biopsy required for patients with recurrent tumors that enhance but whose initial tumor did not

• Measurable disease by radiography

• Meets any of the following criteria:

• Progressive nonresectable disease

• Any location in the brain

• Patients with a less than gross total resection are eligible provided they are symptomatic from their tumor OR the risk from neurologic impairment with progression is high enough to warrant immediate treatment

• Has undergone biopsy only

• Must have received ≥ 1 course of prior chemotherapy (for patients < 10 years of age)

• Prior chemotherapy optional (for patients ≥ 10 years of age)

• No type-1 neurofibromatosis

• No evidence of leptomeningeal dissemination

PATIENT CHARACTERISTICS:

Age

• 3 to 20

Performance status

• ECOG 0-2 OR

• Karnofsky 50-100% (for patients > 16 years of age) OR

• Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

• At least 1 year

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3 (transfusion independent)

• Hemoglobin ≥ 10.0 g/dL (transfusions allowed)

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• Not in status epilepticus, coma, or requiring assisted ventilation prior to study entry

• Patients with a seizure disorder are eligible provided they are on anticonvulsants AND disease is well controlled

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• Recovered from prior chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• Concurrent dexamethasone allowed provided patient has been on a stable dose for ≥ 2 weeks prior to study entry

• Concurrent dexamethasone allowed for symptoms of increased intracranial pressure

Radiotherapy

• No prior radiotherapy

Surgery

• See Disease Characteristics

Other

• No other concurrent anticancer therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB Comprehensive Cancer Center	Birmingham	Alabama	United States	35294
2	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016-7710
3	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
4	Southern California Permanente Medical Group	Downey	California	United States	90027
5	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California	United States	92354
6	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital	Long Beach	California	United States	90801
7	Childrens Hospital Los Angeles	Los Angeles	California	United States	90027
8	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California	United States	90048-1865
9	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California	United States	90095-1781
10	Children's Hospital Central California	Madera	California	United States	93638-8762
11	Children's Hospital and Research Center Oakland	Oakland	California	United States	94609
12	Children's Hospital of Orange County	Orange	California	United States	92868
13	University of California Davis Cancer Center	Sacramento	California	United States	95817
14	Kaiser Permanente Medical Center - Oakland	Sacramento	California	United States	95825
15	Rady Children's Hospital - San Diego	San Diego	California	United States	92123-4282
16	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94115
17	Children's Hospital Center for Cancer and Blood Disorders	Aurora	Colorado	United States	80045
18	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
19	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
20	Alfred I. duPont Hospital for Children	Wilmington	Delaware	United States	19803
21	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
22	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
23	Lee Cancer Care of Lee Memorial Health System	Fort Myers	Florida	United States	33901
24	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida	United States	33021
25	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
26	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida	United States	33136
27	Miami Children's Hospital	Miami	Florida	United States	33155
28	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida	United States	32803-1273
29	M.D. Anderson Cancer Center at Orlando	Orlando	Florida	United States	32806
30	Nemours Children's Clinic - Orlando	Orlando	Florida	United States	32806
31	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida	United States	32504
32	All Children's Hospital	Saint Petersburg	Florida	United States	33701
33	St. Joseph's Cancer Institute at St. Joseph's Hospital	Tampa	Florida	United States	33607
34	Kaplan Cancer Center at St. Mary's Medical Center	West Palm Beach	Florida	United States	33407
35	AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus	Atlanta	Georgia	United States	30322
36	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912-3730
37	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
38	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho	United States	83712-6297
39	University of Illinois Cancer Center	Chicago	Illinois	United States	60612-7243
40	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
41	Keyser Family Cancer Center at Advocate Hope Children's Hospital	Oak Lawn	Illinois	United States	60453
42	Advocate Lutheran General Cancer Care Center	Park Ridge	Illinois	United States	60068-1174
43	Saint Jude Midwest Affiliate	Peoria	Illinois	United States	61637
44	Simmons Cooper Cancer Institute	Springfield	Illinois	United States	62794-9677
45	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
46	St. Vincent Indianapolis Hospital	Indianapolis	Indiana	United States	46260
47	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
48	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
49	Kosair Children's Hospital	Louisville	Kentucky	United States	40232
50	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana	United States	71315-3198
51	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Baltimore	Maryland	United States	21215
52	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
53	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503-2560
54	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
55	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-5381
56	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan	United States	48910
57	Children's Hospitals and Clinics of Minnesota - Minneapolis	Minneapolis	Minnesota	United States	55404
58	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
59	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216-4505
60	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
61	Cardinal Glennon Children's Hospital	Saint Louis	Missouri	United States	63104
62	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
63	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89109-2306
64	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
65	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey	United States	07601
66	Overlook Hospital	Morristown	New Jersey	United States	07962
67	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
68	St. Joseph's Hospital and Medical Center	Paterson	New Jersey	United States	07503
69	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
70	Albert Einstein Cancer Center at Albert Einstein College of Medicine	Bronx	New York	United States	10461
71	Maimonides Cancer Center at Maimonides Medical Center	Brooklyn	New York	United States	11219
72	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
73	Winthrop University Hospital	Mineola	New York	United States	11501
74	NYU Cancer Institute at New York University Medical Center	New York	New York	United States	10016
75	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York	United States	10032
76	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
77	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
78	Stony Brook University Cancer Center	Stony Brook	New York	United States	11794-9446
79	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
80	New York Medical College	Valhalla	New York	United States	10595
81	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
82	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
83	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
84	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
85	Akron Children's Hospital	Akron	Ohio	United States	44308-1062
86	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
87	Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106-5000
88	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
89	Nationwide Children's Hospital	Columbus	Ohio	United States	43205-2696
90	Dayton Children's - Dayton	Dayton	Ohio	United States	45404-1815
91	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
92	Tod Children's Hospital	Youngstown	Ohio	United States	44501
93	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma	United States	73104
94	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon	United States	97227
95	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97239-3098
96	Penn State Children's Hospital	Hershey	Pennsylvania	United States	17033-0850
97	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania	United States	19134-1095
98	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15213
99	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island	United States	02903
100	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
101	Palmetto Health South Carolina Cancer Center	Columbia	South Carolina	United States	29203
102	Greenville Hospital Cancer Center	Greenville	South Carolina	United States	29605
103	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
104	East Tennessee Children's Hospital	Knoxville	Tennessee	United States	37901
105	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105
106	Texas Tech University Health Sciences Center School of Medicine - Amarillo	Amarillo	Texas	United States	79106
107	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78411
108	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
109	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas	United States	76104
110	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
111	Covenant Children's Hospital	Lubbock	Texas	United States	79410
112	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78207
113	Methodist Children's Hospital of South Texas	San Antonio	Texas	United States	78229-3993
114	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
115	Primary Children's Medical Center	Salt Lake City	Utah	United States	84113-1100
116	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont	United States	05401
117	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042-3300
118	Children's Hospital of The King's Daughters	Norfolk	Virginia	United States	23507-1971
119	Carilion Medical Center for Children at Roanoke Community Hospital	Roanoke	Virginia	United States	24014
120	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105
121	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington	United States	99220-2555
122	West Virginia University Health Sciences Center - Charleston	Charleston	West Virginia	United States	25302
123	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital	Huntington	West Virginia	United States	25701
124	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia	United States	26506
125	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
126	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
127	Midwest Children's Cancer Center at Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53226
128	Royal Children's Hospital	Brisbane	Queensland	Australia	4029
129	Princess Margaret Hospital for Children	Perth	Western Australia	Australia	6001
130	Children's & Women's Hospital of British Columbia	Vancouver	British Columbia	Canada	V6H 3V4
131	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
132	IWK Health Centre	Halifax	Nova Scotia	Canada	B3J 3G9
133	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario	Canada	L8N 3Z5
134	Children's Hospital of Western Ontario	London	Ontario	Canada	N6A 5W9
135	Children's Hospital of Eastern Ontario	Ottawa	Ontario	Canada	K1H 8L1
136	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8
137	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
138	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 4H4
139	Centre Hospitalier Universitaire de Quebec	Quebec		Canada	G1V 4G2
140	Starship Children's Health	Auckland		New Zealand	1
141	Christchurch Hospital	Christchurch		New Zealand	8140
142	Wellington Children's Hospital	Wellington		New Zealand	6002
143	San Jorge Children's Hospital	Santurce		Puerto Rico	00912
144	Swiss Pediatric Oncology Group Geneva	Geneva		Switzerland	1205
145	Swiss Pediatric Oncology Group Lausanne	Lausanne		Switzerland	1011

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Joel M. Cherlow, MD, Todd Cancer Institute at Long Beach Memorial Medical Center
• Study Chair: Edward G. Shaw, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT00238264
• Other Study ID Numbers: ACNS0221; COG-ACNS0221; CIRB-05016; CDR0000445095
• First Posted: Oct 13, 2005
• Last Update Posted: Aug 7, 2019
• Last Verified: Nov 1, 2016

• Keywords provided by Children's Oncology Group: childhood oligodendroglioma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; childhood low-grade cerebral astrocytoma; recurrent childhood visual pathway and hypothalamic glioma; untreated childhood cerebellar astrocytoma; untreated childhood visual pathway and hypothalamic glioma
• Additional relevant MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms

Study Results

Participant Flow

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Period Title: Overall Study
STARTED	92
COMPLETED	56
NOT COMPLETED	36

Baseline Characteristics

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Overall Participants	92
Age (Count of Participants)
<=18 years	86 93.5%
Between 18 and 65 years	6 6.5%
>=65 years	0 0%
Age (Years) [Median (Full Range) ]
Median (Full Range) [Years]	13.6
Sex: Female, Male (Count of Participants)
Female	49 53.3%
Male	43 46.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 9.8%
Not Hispanic or Latino	82 89.1%
Unknown or Not Reported	1 1.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 2.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	9 9.8%
White	75 81.5%
More than one race	0 0%
Unknown or Not Reported	6 6.5%

Outcome Measures

1. Primary Outcome

Title	Marginal-failure Rate
Description	Patients who do not recur as well as those with either central or distant recurrence would be treatment successes for this endpoint. Monitoring will be based on a Bayesian rule, with binomial likelihood and a Beta on the parameter p, the proportion of failures that are marginal failures.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

All evaluable patients were included in this analysis (n = 84). One eligible patient was deemed to be not evaluable due to progression during treatment, and was excluded from the analysis per protocol.

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Measure Participants	84
Number [percentage of failure rate]	0

2. Secondary Outcome

Title	Progression-free Survival Probability
Description	To estimate the progression-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

All eligible patients were included in the analysis, per protocol.

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Measure Participants	85
Number (95% Confidence Interval) [Percentage 3-year PFS rate]	77.1

3. Secondary Outcome

Title	Event-free Survival Probability
Description	To estimate the event-free survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

All eligible patients were included in the analysis, per protocol.

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Measure Participants	85
Number (95% Confidence Interval) [Percentage 3-year EFS rate]	77.1

4. Secondary Outcome

Title	Overall Survival Probability
Description	To estimate the overall survival rate for patients with recurrent, progressive or symptomatic low-grade gliomas after treatment with reduced field conformal radiation.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

All eligible patients were included in the analysis, per protocol.

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Measure Participants	85
Number (95% Confidence Interval) [Percentage 3-year OS rate]	94.0

5. Secondary Outcome

Title	Quality of Life (QOL)
Description	QOL accessed using the Behavior Assessment System for Children (BASC), the Adaptive Behavior Assessment System (ABAS), the Behavior Rating Inventory of Executive Function (BRIEF), and the Symptom Checklist-90-R (SCL-90-R).
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

The QOL assessments were removed from the protocol as part of Amendment #1A (as of 10/27/2010) due to extremely low compliance. No QOL data were available for statistical analysis.

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Measure Participants	0

6. Secondary Outcome

Title	MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods
Description	The MIB-1 labeling Index will be calculated as the percentage of tumor nuclei that are immunoreactive.
Time Frame	At baseline

Outcome Measure Data

Analysis Population Description

All eligible patients with MIB-1 labeling index available.

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Measure Participants	64
Number (95% Confidence Interval) [percentage of tumor nuclei]	3.1

7. Secondary Outcome

Title	Correlation MIB-1 Labeling Index With PFS
Description	The primary methods of analysis will be via stratified Cox regression
Time Frame	Up to 10 years

Outcome Measure Data

Analysis Population Description

All eligible patients with MIB-1 data available were included in this analysis. Per protocol, patients were stratified by age and tumor location. Based on a predefined cutoff, patients were categorized as MIB high or low (high: >= 2; low: < 2). The hazard ratio below is for patients with MIB high (low is the reference level).

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Reduced-field conformal radiation therapy 5 days a week for 6 weeks
Measure Participants	64
Number (95% Confidence Interval) [Hazard ratio]	1.08

Adverse Events

Arm/Group Title	Reduced-field Conformal Radiation Therapy
Arm/Group Description	Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. radiation therapy: Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
All Cause Mortality
	Reduced-field Conformal Radiation Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Reduced-field Conformal Radiation Therapy
	Affected / at Risk (%)	# Events
Total	5/85 (5.9%)
Blood and lymphatic system disorders
Anemia	1/85 (1.2%)	1
Eye disorders
Periorbital edema	1/85 (1.2%)	1
Metabolism and nutrition disorders
Hypernatremia	1/85 (1.2%)	1
Hypokalemia	1/85 (1.2%)	1
Hyponatremia	1/85 (1.2%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/85 (1.2%)	1
Nervous system disorders
Abducens nerve disorder	1/85 (1.2%)	1
Encephalopathy	1/85 (1.2%)	1
Hydrocephalus	2/85 (2.4%)	2
Nervous system disorders - Other, specify	1/85 (1.2%)	1
Neuralgia	1/85 (1.2%)	1
Oculomotor nerve disorder	1/85 (1.2%)	1
Peripheral sensory neuropathy	1/85 (1.2%)	1
Tremor	1/85 (1.2%)	1
Trigeminal nerve disorder	1/85 (1.2%)	1
Psychiatric disorders
Depression	1/85 (1.2%)	1
Other (Not Including Serious) Adverse Events
	Reduced-field Conformal Radiation Therapy
	Affected / at Risk (%)	# Events
Total	5/85 (5.9%)
Nervous system disorders
Headache	5/85 (5.9%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Must obtain prior Sponsor approval.