Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

• Sponsor: Radiation Therapy Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00057746
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 265
• Locations: 222
• Arms: 3
• Duration (Months): 129
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy.

PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Radiation: Prophylactic cranial irradiation, 2.5 Gy fx; Radiation: Prophylactic cranial irradiation, 2.0 Gy fx; Radiation: Prophylactic cranial irradiation, 1.5 Gy fx	Phase 2

Detailed Description

OBJECTIVES:

• Compare the incidence of chronic neurotoxicity in patients treated with these regimens.

• Compare quality of life of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.

• Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity.

• Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.

Patients are followed every 6 months for 1 year and then annually for 3 years.

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 265 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I Prophylactic cranial irradiation, 2.5 Gy fx	Radiation: Prophylactic cranial irradiation, 2.5 Gy fx; Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy; Other Names: PCI
Experimental: Arm II Prophylactic cranial irradiation, 2.0 Gy fx	Radiation: Prophylactic cranial irradiation, 2.0 Gy fx; Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy; Other Names: PCI
Experimental: Arm III Prophylactic cranial irradiation, 1.5 Gy fx	Radiation: Prophylactic cranial irradiation, 1.5 Gy fx; Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy; Other Names: PCI

Outcome Measures

Primary Outcome Measures

1. Incidence of Chronic Neurotoxicity [From study registration to one year.]

   Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa

• Limited stage (I-IIIB)

• Confined to 1 hemithorax

• No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement

• Complete response after induction chemotherapy (with or without thoracic radiotherapy)

• Consolidative chest radiotherapy may be initiated before study

• No radiographic evidence of any of the following:

• Brain metastases

• Normal brain CT scan or MRI less than 1 month before study

• Ipsilateral lung metastases

• Malignant pleural effusion

• Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 75,000/mm^3

• Hemoglobin at least 10.0 g/dL^

Hepatic

• Not specified

Renal

• Not specified

Pulmonary

• See Disease Characteristics

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Neurological function class 1 or 2

• No epilepsy requiring permanent oral medication

• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No other serious medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• At least 1 week since prior chemotherapy

• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy

• Concurrent thoracic radiotherapy allowed

Surgery

• Not specified

Other

• No concurrent antitumor agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama	United States	35294
2	Arizona Oncology Services Foundation	Phoenix	Arizona	United States	85013
3	Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn	Scottsdale	Arizona	United States	85251
4	Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea	Scottsdale	Arizona	United States	85260
5	Highlands Oncology Group - Springdale	Springdale	Arkansas	United States	72764
6	Auburn Radiation Oncology	Auburn	California	United States	95603
7	Radiation Oncology Centers - Cameron Park	Cameron Park	California	United States	95682
8	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
9	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609
10	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center	Pomona	California	United States	91767
11	Radiation Oncology Center - Roseville	Roseville	California	United States	95661
12	Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	California	United States	95815
13	Mercy General Hospital	Sacramento	California	United States	95819
14	Solano Radiation Oncology Center	Vacaville	California	United States	95687
15	Memorial Hospital Cancer Center - Colorado Springs	Colorado Springs	Colorado	United States	80909
16	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
17	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
18	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
19	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-0232
20	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida	United States	33136
21	Baptist-South Miami Regional Cancer Program	Miami	Florida	United States	33176
22	Bay Medical	Panama City	Florida	United States	32401
23	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
24	Northwest Community Hospital	Arlington Heights	Illinois	United States	60005
25	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
26	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
27	Graham Hospital	Canton	Illinois	United States	61520
28	Memorial Hospital	Carthage	Illinois	United States	62321
29	St. Anthony's Memorial Hospital	Effingham	Illinois	United States	62401
30	Eureka Community Hospital	Eureka	Illinois	United States	61530
31	Galesburg Clinic, PC	Galesburg	Illinois	United States	61401
32	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
33	InterCommunity Cancer Center of Western Illinois	Galesburg	Illinois	United States	61401
34	Mason District Hospital	Havana	Illinois	United States	62644
35	Hopedale Medical Complex	Hopedale	Illinois	United States	61747
36	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
37	Kewanee Hospital	Kewanee	Illinois	United States	61443
38	La Grange Memorial Hospital	La Grange	Illinois	United States	60525
39	McDonough District Hospital	Macomb	Illinois	United States	61455
40	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
41	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
42	Community Cancer Center	Normal	Illinois	United States	61761
43	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
44	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
45	Proctor Hospital	Peoria	Illinois	United States	61614
46	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
47	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
48	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
49	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
50	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
51	Perry Memorial Hospital	Princeton	Illinois	United States	61356
52	St. Margaret's Hospital	Spring Valley	Illinois	United States	61362
53	Valley Cancer Center	Spring Valley	Illinois	United States	61362
54	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
55	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
56	Saint John's Cancer Center at Saint John's Medical Center	Anderson	Indiana	United States	46016
57	Parkview Regional Cancer Center at Parkview Health	Fort Wayne	Indiana	United States	46805
58	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
59	Veterans Affairs Medical Center - Indianapolis	Indianapolis	Indiana	United States	46202
60	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
61	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
62	Cancer Center at Ball Memorial Hospital	Muncie	Indiana	United States	47303-3499
63	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
64	McFarland Clinic, PC	Ames	Iowa	United States	50010
65	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
66	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
67	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
68	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
69	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
70	Southwest Medical Center	Liberal	Kansas	United States	67901
71	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
72	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
73	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
74	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
75	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
76	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
77	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
78	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67203
79	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
80	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
81	CCOP - Wichita	Wichita	Kansas	United States	67214
82	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
83	Wesley Medical Center	Wichita	Kansas	United States	67214
84	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
85	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
86	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
87	Union Hospital Cancer Program at Union Hospital	Elkton MD	Maryland	United States	21921
88	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
89	Hudner Oncology Center at Saint Anne's Hospital - Fall River	Fall River	Massachusetts	United States	02721
90	South Suburban Oncology Center	Quincy	Massachusetts	United States	02169
91	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
92	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan	United States	48105
93	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
94	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
95	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
96	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
97	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
98	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
99	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
100	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
101	Metro Health Hospital	Grand Rapids	Michigan	United States	49506
102	Holland Community Hospital	Holland	Michigan	United States	49423
103	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
104	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
105	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
106	Hackley Hospital	Muskegon	Michigan	United States	49442
107	Lakeland Regional Cancer Care Center - St. Joseph	St. Joseph	Michigan	United States	49085
108	Munson Medical Center	Traverse City	Michigan	United States	49684
109	Immanuel St. Joseph's	Mankato	Minnesota	United States	56002
110	CentraCare Clinic - River Campus	St. Cloud	Minnesota	United States	56303
111	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
112	Cancer Institute of Cape Girardeau, LLC	Cape Girardeau	Missouri	United States	63703
113	CCOP - St. Louis-Cape Girardeau	St. Louis	Missouri	United States	63141
114	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
115	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
116	Radiation Oncology Associates - Reno	Reno	Nevada	United States	89509
117	Ocean Medical Center at Meridian Health	Brick	New Jersey	United States	08724
118	John F. Kennedy Medical Center	Edison	New Jersey	United States	08818
119	Monmouth Medical Center	Long Branch	New Jersey	United States	07740-6395
120	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey	United States	08053
121	Booker Cancer Center at Riverview Medical Center	Red Bank	New Jersey	United States	07701
122	Frederick R. and Betty M. Smith Cancer Treatment Center	Sparta	New Jersey	United States	07871
123	J. Phillip Citta Regional Cancer Center at Community Medical Center	Toms River	New Jersey	United States	08755
124	Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare	Vineland	New Jersey	United States	08360
125	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
126	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
127	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
128	Hudson Valley Oncology Associates	Poughkeepsie	New York	United States	12601
129	Highland Hospital of Rochester	Rochester	New York	United States	14620
130	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
131	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
132	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
133	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
134	Wayne Radiation Oncology	Goldsboro	North Carolina	United States	27534
135	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina	United States	27835-6028
136	Kinston Medical Specialists	Kinston	North Carolina	United States	28501
137	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
138	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio	United States	44309-2090
139	Aultman Cancer Center at Aultman Hospital	Canton	Ohio	United States	44710-1799
140	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
141	Huron Hospital Cancer Care Center	Cleveland	Ohio	United States	44112
142	Euclid Hospital	Cleveland	Ohio	United States	44119
143	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
144	St. Rita's Medical Center	Lima	Ohio	United States	45801
145	Lima Memorial Hospital	Lima	Ohio	United States	45804
146	MedCentral - Mansfield Hospital	Mansfield	Ohio	United States	44903
147	St. Luke's Hospital	Maumee	Ohio	United States	43537
148	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio	United States	44124
149	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
150	Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford	Salem	Ohio	United States	44460
151	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
152	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
153	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
154	Toledo Hospital	Toledo	Ohio	United States	43606
155	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
156	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
157	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
158	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
159	South Pointe Hospital Cancer Care Center	Warrensville Heights	Ohio	United States	44122
160	Cancer Treatment Center	Wooster	Ohio	United States	44691
161	Three Rivers Community Hospital	Grants Pass	Oregon	United States	97527
162	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
163	Dubs Cancer Center at Rogue Valley Medical Center	Medford	Oregon	United States	97504
164	Providence Cancer Center at PMCC	Medford	Oregon	United States	97504
165	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
166	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon	United States	97210
167	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
168	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
169	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
170	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon	United States	97227
171	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
172	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
173	St. Luke's Cancer Network at St. Luke's Hospital	Bethlehem	Pennsylvania	United States	18015
174	Dale and Frances Hughes Cancer Center at Pocono Medical Center	East Stroudsburg	Pennsylvania	United States	18301
175	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
176	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
177	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
178	Fox Chase Cancer Center CCOP Research Base	Philadelphia	Pennsylvania	United States	19140
179	Albert Einstein Cancer Center	Philadelphia	Pennsylvania	United States	19141
180	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania	United States	19612-6052
181	York Cancer Center at Apple Hill Medical Center	York	Pennsylvania	United States	17405
182	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
183	CCOP - Greenville	Greenville	South Carolina	United States	29615
184	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
185	Arlington Cancer Center - Arlington	Arlington	Texas	United States	76012-2510
186	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
187	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
188	Cottonwood Hospital Medical Center	Murray	Utah	United States	84107
189	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
190	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
191	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
192	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
193	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
194	LDS Hospital	Salt Lake City	Utah	United States	84143
195	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
196	Harrison Medical Center	Bremerton	Washington	United States	98310
197	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98104
198	Harborview Medical Center	Seattle	Washington	United States	98104
199	Group Health Central Hospital	Seattle	Washington	United States	98112
200	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
201	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
202	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
203	Madigan Army Medical Center - Tacoma	Tacoma	Washington	United States	98431
204	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98668
205	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
206	Schiffler Cancer Center at Wheeling Hospital	Wheeling	West Virginia	United States	26003
207	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
208	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
209	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
210	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
211	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
212	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
213	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
214	Veterans Affairs Medical Center - Milwaukee	Milwaukee	Wisconsin	United States	53295
215	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin	United States	53066
216	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin	United States	53405
217	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin	United States	53188
218	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
219	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
220	Hopital Notre-Dame du CHUM	Montreal	Quebec	Canada	H2L 4M1
221	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec	Canada	G1R 2J6
222	McGill Cancer Centre at McGill University	Montreal		Canada	H2W 1S6

Sponsors and Collaborators

• Radiation Therapy Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Aaron H. Wolfson, MD, University of Miami Sylvester Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.
• Le Péchoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20.
• Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.

• Responsible Party: Radiation Therapy Oncology Group
• ClinicalTrials.gov Identifier: NCT00057746
• Other Study ID Numbers: RTOG-0212; CDR0000258668
• First Posted: Apr 9, 2003
• Last Update Posted: May 25, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Radiation Therapy Oncology Group: limited stage small cell lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma

Study Results

Participant Flow

Arm/Group Title	Arm I	Arm II	Arm III
Arm/Group Description	Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
Period Title: Overall Study
STARTED	131	67	67
COMPLETED	131	67	66
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Arm I	Arm II	Arm III	Total
Arm/Group Description	Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy	Total of all reporting groups
Overall Participants	131	67	66	264
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62	62	61	62
Sex: Female, Male (Count of Participants)
Female	53 40.5%	33 49.3%	32 48.5%	118 44.7%
Male	78 59.5%	34 50.7%	34 51.5%	146 55.3%

Outcome Measures

1. Primary Outcome

Title	Incidence of Chronic Neurotoxicity
Description	Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.
Time Frame	From study registration to one year.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I	Arm II	Arm III
Arm/Group Description	Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
Measure Participants	45	20	19
Number (95% Confidence Interval) [percentage of participants]	60 45.8%	85 126.9%	89 134.8%

Adverse Events

Adverse Event Reporting Description	Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Arm/Group Title	Arm I		Arm II		Arm III
Arm/Group Description	Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy		Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy		Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
All Cause Mortality
	Arm I		Arm II		Arm III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I		Arm II		Arm III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/128 (4.7%)		2/66 (3%)		4/64 (6.3%)
Gastrointestinal disorders
Abdominal pain or cramping	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Dysphagia-esophageal related to radiation	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Nausea	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Vomiting	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
General disorders
Constitutional Symptoms - Other, Specify	0/128 (0%)		0/66 (0%)		1/64 (1.6%)
Edema	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Fatigue	0/128 (0%)		1/66 (1.5%)		0/64 (0%)
Investigations
Weight loss	0/128 (0%)		0/66 (0%)		1/64 (1.6%)
Metabolism and nutrition disorders
Anorexia	0/128 (0%)		0/66 (0%)		1/64 (1.6%)
Hypocalcemia	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Hypokalemia	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Hypomagnesemia	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Metabolic/laboratory-Other	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain	0/128 (0%)		1/66 (1.5%)		0/64 (0%)
Nervous system disorders
Brain	0/128 (0%)		0/66 (0%)		1/64 (1.6%)
Confusion	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Neuropathy - motor	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Syncope	0/128 (0%)		0/66 (0%)		1/64 (1.6%)
Vertigo	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Pneumonitis/pulmonary infiltrates	1/128 (0.8%)		0/66 (0%)		2/64 (3.1%)
Pulmonary-Other	1/128 (0.8%)		0/66 (0%)		0/64 (0%)
Other (Not Including Serious) Adverse Events
	Arm I		Arm II		Arm III
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/128 (42.2%)		37/66 (56.1%)		26/64 (40.6%)
Gastrointestinal disorders
Nausea or vomiting	21/128 (16.4%)		18/66 (27.3%)		11/64 (17.2%)
General disorders
Fatigue	35/128 (27.3%)		25/66 (37.9%)		17/64 (26.6%)
Nervous system disorders
Headache	31/128 (24.2%)		21/66 (31.8%)		19/64 (29.7%)
Psychiatric disorders
Insomnia	5/128 (3.9%)		4/66 (6.1%)		4/64 (6.3%)

Limitations/Caveats

The number of inevaluable patients at one year (e.g., patients dying prior to 1 year, patients not completing the neurocognitive battery at 1 year) was greater than anticipated.

More Information

Certain Agreements

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

PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.