ClinicalTrials.gov

History of Changes for Study: NCT00392327
Chemotherapy and Radiation Therapy in Treating Young Patients Who Have Undergone Surgery for Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor
Latest version (submitted January 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 25, 2006 None (earliest Version on record)
2 November 8, 2006 Study Design, Conditions, Study Status, Outcome Measures, Study Description and Study Identification
3 November 21, 2006 Arms and Interventions, Conditions, Study Description, Study Status, Eligibility, Study Design and Study Identification
4 January 11, 2007 Study Status
5 February 20, 2007 Eligibility, Study Description and Study Status
6 April 9, 2007 Study Status
7 April 18, 2007 Recruitment Status, Study Status and Contacts/Locations
8 May 3, 2007 Contacts/Locations and Study Status
9 May 8, 2007 Study Status and Contacts/Locations
10 May 16, 2007 Contacts/Locations and Study Status
11 May 23, 2007 Contacts/Locations and Study Status
12 June 4, 2007 Contacts/Locations and Study Status
13 June 6, 2007 Study Status and Contacts/Locations
14 June 13, 2007 Contacts/Locations and Study Status
15 June 20, 2007 Contacts/Locations and Study Status
16 June 25, 2007 Contacts/Locations and Study Status
17 July 3, 2007 Contacts/Locations and Study Status
18 July 10, 2007 Contacts/Locations and Study Status
19 July 17, 2007 Contacts/Locations and Study Status
20 July 30, 2007 Contacts/Locations and Study Status
21 August 8, 2007 Contacts/Locations and Study Status
22 August 14, 2007 Contacts/Locations and Study Status
23 August 21, 2007 Contacts/Locations and Study Status
24 August 24, 2007 Contacts/Locations and Study Status
25 August 31, 2007 Contacts/Locations and Study Status
26 September 7, 2007 Contacts/Locations and Study Status
27 September 10, 2007 Contacts/Locations and Study Status
28 September 20, 2007 Contacts/Locations and Study Status
29 September 25, 2007 Contacts/Locations and Study Status
30 September 27, 2007 Contacts/Locations and Study Status
31 October 5, 2007 Study Status, Contacts/Locations, Eligibility and Study Description
32 October 13, 2007 Contacts/Locations, Eligibility, Study Description and Study Status
33 October 17, 2007 Contacts/Locations and Study Status
34 October 26, 2007 Arms and Interventions, Contacts/Locations and Study Status
35 November 2, 2007 Contacts/Locations and Study Status
36 November 9, 2007 Contacts/Locations and Study Status
37 November 14, 2007 Contacts/Locations and Study Status
38 November 15, 2007 Contacts/Locations and Study Status
39 November 16, 2007 Contacts/Locations and Study Status
40 November 17, 2007 Contacts/Locations and Study Status
41 November 22, 2007 Contacts/Locations and Study Status
42 November 24, 2007 Contacts/Locations and Study Status
43 November 28, 2007 Arms and Interventions and Study Status
44 December 1, 2007 Contacts/Locations and Study Status
45 December 6, 2007 Study Status, Contacts/Locations and Conditions
46 December 7, 2007 Contacts/Locations, Conditions and Study Status
47 December 8, 2007 Contacts/Locations and Study Status
48 December 13, 2007 Contacts/Locations and Study Status
49 December 19, 2007 Contacts/Locations and Study Status
50 December 25, 2007 Study Status
51 December 28, 2007 Contacts/Locations and Study Status
52 January 11, 2008 Contacts/Locations, Study Status and Arms and Interventions
53 January 12, 2008 Contacts/Locations and Study Status
54 January 17, 2008 Contacts/Locations and Study Status
55 January 18, 2008 Contacts/Locations and Study Status
56 January 19, 2008 Contacts/Locations and Study Status
57 January 22, 2008 Contacts/Locations and Study Status
58 January 23, 2008 Contacts/Locations and Study Status
59 February 2, 2008 Conditions, Eligibility, Study Description and Study Status
60 February 5, 2008 Conditions and Study Status
61 February 7, 2008 Study Status and Contacts/Locations
62 February 9, 2008 Contacts/Locations and Study Status
63 February 14, 2008 Contacts/Locations and Study Status
64 February 15, 2008 Contacts/Locations and Study Status
65 February 19, 2008 Contacts/Locations and Study Status
66 February 22, 2008 Contacts/Locations and Study Status
67 February 27, 2008 Contacts/Locations and Study Status
68 February 28, 2008 Contacts/Locations and Study Status
69 March 7, 2008 Study Status and Contacts/Locations
70 March 13, 2008 Contacts/Locations and Study Status
71 March 17, 2008 Contacts/Locations and Study Status
72 March 18, 2008 Contacts/Locations and Study Status
73 March 22, 2008 Contacts/Locations and Study Status
74 March 25, 2008 Contacts/Locations and Study Status
75 March 28, 2008 Contacts/Locations and Study Status
76 March 29, 2008 Contacts/Locations and Study Status
77 April 1, 2008 Contacts/Locations and Study Status
78 April 2, 2008 Contacts/Locations and Study Status
79 April 3, 2008 Study Status and Contacts/Locations
80 April 4, 2008 Contacts/Locations and Study Status
81 April 8, 2008 Contacts/Locations and Study Status
82 April 10, 2008 Contacts/Locations and Study Status
83 April 16, 2008 Contacts/Locations and Study Status
84 April 17, 2008 Contacts/Locations and Study Status
85 April 18, 2008 Contacts/Locations and Study Status
86 April 22, 2008 Contacts/Locations and Study Status
87 April 24, 2008 Contacts/Locations and Study Status
88 April 25, 2008 Contacts/Locations and Study Status
89 April 26, 2008 Contacts/Locations and Study Status
90 April 30, 2008 Contacts/Locations and Study Status
91 May 6, 2008 Study Status and Contacts/Locations
92 May 13, 2008 Study Status
93 May 16, 2008 Contacts/Locations and Study Status
94 May 18, 2008 Contacts/Locations and Study Status
95 May 20, 2008 Contacts/Locations and Study Status
96 May 24, 2008 Contacts/Locations, Arms and Interventions and Study Status
97 May 27, 2008 Contacts/Locations and Study Status
98 May 29, 2008 Arms and Interventions and Study Status
99 May 30, 2008 Contacts/Locations and Study Status
100 June 6, 2008 Contacts/Locations and Study Status
101 June 10, 2008 Contacts/Locations and Study Status
102 June 11, 2008 Contacts/Locations and Study Status
103 June 13, 2008 Contacts/Locations, Arms and Interventions and Study Status
104 June 21, 2008 Contacts/Locations and Study Status
105 June 24, 2008 Contacts/Locations and Study Status
106 June 28, 2008 Contacts/Locations and Study Status
107 July 1, 2008 Contacts/Locations and Study Status
108 July 2, 2008 Study Status and Contacts/Locations
109 July 9, 2008 Contacts/Locations and Study Status
110 July 12, 2008 Contacts/Locations and Study Status
111 July 19, 2008 Contacts/Locations and Study Status
112 July 22, 2008 Contacts/Locations and Study Status
113 July 23, 2008 Study Design and Study Status
114 July 26, 2008 Contacts/Locations and Study Status
115 August 13, 2008 Contacts/Locations and Study Status
116 August 16, 2008 Contacts/Locations and Study Status
117 August 20, 2008 Contacts/Locations and Study Status
118 August 23, 2008 Arms and Interventions and Study Status
119 September 2, 2008 Contacts/Locations and Study Status
120 September 6, 2008 Study Status and Contacts/Locations
121 September 9, 2008 Contacts/Locations and Study Status
122 September 10, 2008 Contacts/Locations and Study Status
123 September 12, 2008 Contacts/Locations and Study Status
124 September 13, 2008 Contacts/Locations and Study Status
125 September 22, 2008 Contacts/Locations and Study Status
126 October 3, 2008 Study Status and Contacts/Locations
127 October 12, 2008 Contacts/Locations and Study Status
128 October 16, 2008 Contacts/Locations and Study Status
129 October 22, 2008 Study Status
130 October 24, 2008 Eligibility and Study Status
131 October 31, 2008 Contacts/Locations and Study Status
132 November 1, 2008 Contacts/Locations and Study Status
133 November 4, 2008 Study Status and Contacts/Locations
134 November 12, 2008 Contacts/Locations and Study Status
135 November 16, 2008 Contacts/Locations and Study Status
136 November 18, 2008 Contacts/Locations and Study Status
137 November 19, 2008 Contacts/Locations and Study Status
138 November 21, 2008 Contacts/Locations and Study Status
139 December 2, 2008 Study Status and Contacts/Locations
140 December 20, 2008 Contacts/Locations and Study Status
141 December 31, 2008 Contacts/Locations and Study Status
142 January 2, 2009 Study Status and Contacts/Locations
143 January 9, 2009 Contacts/Locations and Study Status
144 January 13, 2009 Contacts/Locations and Study Status
145 January 14, 2009 Contacts/Locations and Study Status
146 January 15, 2009 Contacts/Locations and Study Status
147 January 16, 2009 Contacts/Locations and Study Status
148 January 21, 2009 Contacts/Locations and Study Status
149 January 23, 2009 Contacts/Locations and Study Status
150 January 27, 2009 Contacts/Locations and Study Status
151 January 29, 2009 Contacts/Locations and Study Status
152 February 6, 2009 Arms and Interventions and Study Status
153 February 21, 2009 Contacts/Locations and Study Status
154 March 3, 2009 Contacts/Locations and Study Status
155 March 12, 2009 Study Status and Contacts/Locations
156 March 21, 2009 Contacts/Locations and Study Status
157 March 31, 2009 Contacts/Locations and Study Status
158 April 1, 2009 Contacts/Locations and Study Status
159 April 2, 2009 Contacts/Locations and Study Status
160 April 3, 2009 Contacts/Locations and Study Status
161 April 4, 2009 Contacts/Locations and Study Status
162 April 9, 2009 Contacts/Locations and Study Status
163 April 14, 2009 Contacts/Locations, Sponsor/Collaborators and Study Status
164 April 23, 2009 Contacts/Locations and Study Status
165 April 24, 2009 Contacts/Locations and Study Status
166 April 26, 2009 Contacts/Locations and Study Status
167 April 28, 2009 Contacts/Locations and Study Status
168 April 29, 2009 Contacts/Locations and Study Status
169 May 2, 2009 Study Status and Contacts/Locations
170 May 7, 2009 Contacts/Locations and Study Status
171 May 12, 2009 Contacts/Locations and Study Status
172 May 14, 2009 Contacts/Locations and Study Status
173 May 16, 2009 Contacts/Locations and Study Status
174 May 22, 2009 Contacts/Locations and Study Status
175 May 26, 2009 Contacts/Locations and Study Status
176 May 30, 2009 Contacts/Locations and Study Status
177 June 4, 2009 Study Status and Contacts/Locations
178 June 9, 2009 Contacts/Locations and Study Status
179 June 10, 2009 Contacts/Locations and Study Status
180 June 16, 2009 Contacts/Locations and Study Status
181 June 17, 2009 Contacts/Locations and Study Status
182 June 20, 2009 Contacts/Locations and Study Status
183 June 30, 2009 Contacts/Locations and Study Status
184 July 4, 2009 Study Status and Contacts/Locations
185 July 15, 2009 Contacts/Locations and Study Status
186 July 16, 2009 Contacts/Locations and Study Status
187 July 17, 2009 Contacts/Locations and Study Status
188 August 8, 2009 Study Status
189 August 11, 2009 Study Status
190 August 13, 2009 Contacts/Locations and Study Status
191 August 20, 2009 Contacts/Locations and Study Status
192 August 27, 2009 Contacts/Locations and Study Status
193 September 1, 2009 Contacts/Locations and Study Status
194 September 4, 2009 Study Status and Contacts/Locations
195 September 11, 2009 Contacts/Locations and Study Status
196 September 15, 2009 Contacts/Locations and Study Status
197 September 17, 2009 Contacts/Locations and Study Status
198 September 19, 2009 Contacts/Locations and Study Status
199 September 22, 2009 Contacts/Locations and Study Status
200 September 23, 2009 Contacts/Locations and Study Status
201 September 24, 2009 Contacts/Locations and Study Status
202 September 26, 2009 Contacts/Locations and Study Status
203 September 29, 2009 Contacts/Locations and Study Status
204 September 30, 2009 Contacts/Locations and Study Status
205 October 2, 2009 Study Status
206 October 6, 2009 Contacts/Locations and Study Status
207 October 13, 2009 Contacts/Locations and Study Status
208 October 17, 2009 Contacts/Locations and Study Status
209 October 20, 2009 Contacts/Locations and Study Status
210 October 22, 2009 Contacts/Locations and Study Status
211 October 29, 2009 Contacts/Locations and Study Status
212 October 30, 2009 Contacts/Locations and Study Status
213 November 3, 2009 Contacts/Locations and Study Status
214 November 6, 2009 Contacts/Locations and Study Status
215 November 7, 2009 Contacts/Locations and Study Status
216 November 10, 2009 Contacts/Locations and Study Status
217 November 12, 2009 Contacts/Locations and Study Status
218 November 13, 2009 Contacts/Locations and Study Status
219 November 16, 2009 Contacts/Locations and Study Status
220 December 1, 2009 Contacts/Locations and Study Status
221 December 2, 2009 Study Status
222 December 3, 2009 Contacts/Locations and Study Status
223 December 4, 2009 Contacts/Locations and Study Status
224 December 5, 2009 Contacts/Locations and Study Status
225 December 11, 2009 Contacts/Locations and Study Status
226 December 15, 2009 Contacts/Locations and Study Status
227 December 17, 2009 Study Status
228 December 19, 2009 Contacts/Locations and Study Status
229 December 22, 2009 Contacts/Locations and Study Status
230 December 26, 2009 Contacts/Locations and Study Status
231 December 30, 2009 Contacts/Locations and Study Status
232 January 2, 2010 Study Status
233 January 5, 2010 Contacts/Locations and Study Status
234 January 6, 2010 Contacts/Locations and Study Status
235 January 8, 2010 Contacts/Locations and Study Status
236 January 12, 2010 Contacts/Locations and Study Status
237 January 13, 2010 Contacts/Locations and Study Status
238 January 14, 2010 Contacts/Locations and Study Status
239 January 16, 2010 Contacts/Locations and Study Status
240 January 23, 2010 Contacts/Locations and Study Status
241 January 27, 2010 Contacts/Locations and Study Status
242 February 2, 2010 Study Status
243 February 3, 2010 Contacts/Locations and Study Status
244 February 6, 2010 Contacts/Locations and Study Status
245 February 16, 2010 Contacts/Locations and Study Status
246 February 18, 2010 Contacts/Locations and Study Status
247 February 24, 2010 Contacts/Locations and Study Status
248 February 26, 2010 Contacts/Locations and Study Status
249 March 2, 2010 Study Status
250 March 3, 2010 Contacts/Locations and Study Status
251 March 4, 2010 Contacts/Locations and Study Status
252 March 9, 2010 Contacts/Locations and Study Status
253 March 11, 2010 Contacts/Locations and Study Status
254 March 30, 2010 Contacts/Locations and Study Status
255 April 2, 2010 Study Status
256 April 6, 2010 Contacts/Locations and Study Status
257 April 10, 2010 Contacts/Locations and Study Status
258 April 15, 2010 Contacts/Locations and Study Status
259 April 20, 2010 Contacts/Locations and Study Status
260 April 22, 2010 Contacts/Locations and Study Status
261 May 3, 2010 Contacts/Locations and Study Status
262 May 5, 2010 Study Status and Contacts/Locations
263 May 6, 2010 Study Status
264 May 7, 2010 Contacts/Locations and Study Status
265 May 8, 2010 Contacts/Locations and Study Status
266 May 12, 2010 Contacts/Locations and Study Status
267 May 19, 2010 Contacts/Locations and Study Status
268 May 22, 2010 Contacts/Locations and Study Status
269 May 26, 2010 Contacts/Locations and Study Status
270 June 1, 2010 Contacts/Locations and Study Status
271 June 2, 2010 Study Status
272 June 4, 2010 Contacts/Locations and Study Status
273 June 5, 2010 Contacts/Locations and Study Status
274 June 8, 2010 Contacts/Locations and Study Status
275 June 9, 2010 Contacts/Locations and Study Status
276 June 15, 2010 Contacts/Locations and Study Status
277 June 22, 2010 Contacts/Locations and Study Status
278 June 23, 2010 Contacts/Locations and Study Status
279 June 30, 2010 Contacts/Locations and Study Status
280 July 2, 2010 Study Status
281 July 6, 2010 Contacts/Locations and Study Status
282 July 9, 2010 Contacts/Locations and Study Status
283 July 13, 2010 Contacts/Locations and Study Status
284 July 14, 2010 Contacts/Locations and Study Status
285 July 15, 2010 Contacts/Locations and Study Status
286 July 16, 2010 Contacts/Locations and Study Status
287 July 17, 2010 Contacts/Locations and Study Status
288 July 23, 2010 Contacts/Locations and Study Status
289 July 27, 2010 Contacts/Locations and Study Status
290 July 28, 2010 Contacts/Locations and Study Status
291 July 31, 2010 Contacts/Locations and Study Status
292 August 3, 2010 Contacts/Locations and Study Status
293 August 7, 2010 Contacts/Locations and Study Status
294 September 2, 2010 Study Status
295 September 16, 2010 Contacts/Locations and Study Status
296 October 6, 2010 Study Status
297 November 2, 2010 Study Status
298 November 20, 2010 Contacts/Locations and Study Status
299 December 2, 2010 Study Status
300 December 4, 2010 Contacts/Locations and Study Status
301 December 30, 2010 Eligibility, Study Description and Study Status
302 January 1, 2011 Eligibility, Study Description and Study Status
303 January 4, 2011 Study Status
304 January 7, 2011 Contacts/Locations and Study Status
305 January 11, 2011 Study Status
306 January 20, 2011 Study Description and Study Status
307 January 25, 2011 Contacts/Locations and Study Status
308 February 2, 2011 Study Status
309 February 9, 2011 Contacts/Locations and Study Status
310 March 2, 2011 Study Status
311 March 15, 2011 Contacts/Locations and Study Status
312 March 25, 2011 Contacts/Locations and Study Status
313 April 2, 2011 Study Status and Contacts/Locations
314 April 5, 2011 Contacts/Locations and Study Status
315 April 9, 2011 Contacts/Locations and Study Status
316 April 13, 2011 Contacts/Locations and Study Status
317 May 6, 2011 Study Status and Contacts/Locations
318 May 13, 2011 Contacts/Locations and Study Status
319 June 7, 2011 Study Status
320 June 15, 2011 Contacts/Locations and Study Status
321 July 5, 2011 Study Status and Contacts/Locations
322 July 14, 2011 Contacts/Locations and Study Status
323 July 30, 2011 Contacts/Locations and Study Status
324 August 3, 2011 Contacts/Locations and Study Status
325 August 5, 2011 Contacts/Locations and Study Status
326 August 17, 2011 Contacts/Locations and Study Status
327 August 18, 2011 Contacts/Locations and Study Status
328 August 27, 2011 Contacts/Locations and Study Status
329 September 15, 2011 Contacts/Locations and Study Status
330 October 6, 2011 Study Status and Contacts/Locations
331 October 11, 2011 Contacts/Locations and Study Status
332 October 19, 2011 Contacts/Locations and Study Status
333 October 20, 2011 Contacts/Locations and Study Status
334 October 25, 2011 Contacts/Locations and Study Status
335 October 26, 2011 Contacts/Locations and Study Status
336 October 27, 2011 Contacts/Locations and Study Status
337 November 2, 2011 Study Status and Contacts/Locations
338 November 9, 2011 Contacts/Locations and Study Status
339 November 18, 2011 Contacts/Locations and Study Status
340 December 7, 2011 Contacts/Locations and Study Status
341 January 7, 2012 Study Status
342 January 19, 2012 Contacts/Locations and Study Status
343 February 3, 2012 Study Status and Contacts/Locations
344 February 5, 2012 Contacts/Locations and Study Status
345 February 19, 2012 Contacts/Locations and Study Status
346 March 2, 2012 Study Status and Contacts/Locations
347 March 10, 2012 Contacts/Locations and Study Status
348 March 27, 2012 Contacts/Locations and Study Status
349 April 18, 2012 Study Status and Contacts/Locations
350 May 2, 2012 Study Status and Contacts/Locations
351 May 25, 2012 Contacts/Locations and Study Status
352 May 27, 2012 Contacts/Locations and Study Status
353 June 5, 2012 Study Status and Contacts/Locations
354 June 6, 2012 Contacts/Locations and Study Status
355 June 15, 2012 Contacts/Locations and Study Status
356 June 17, 2012 Contacts/Locations and Study Status
357 June 19, 2012 Contacts/Locations and Study Status
358 June 25, 2012 Contacts/Locations and Study Status
359 July 12, 2012 Study Status and Contacts/Locations
360 July 18, 2012 Contacts/Locations and Study Status
361 July 24, 2012 Contacts/Locations and Study Status
362 July 27, 2012 Contacts/Locations and Study Status
363 August 3, 2012 Contacts/Locations and Study Status
364 August 12, 2012 Contacts/Locations and Study Status
365 August 15, 2012 Contacts/Locations and Study Status
366 August 16, 2012 Contacts/Locations and Study Status
367 September 12, 2012 Study Status
368 October 3, 2012 Study Status and Contacts/Locations
369 October 24, 2012 Contacts/Locations and Study Status
370 November 3, 2012 Study Status
371 June 10, 2013 Contacts/Locations, Arms and Interventions, Outcome Measures, Study Identification, Sponsor/Collaborators, Study Status, Conditions, Study Description, Eligibility, Study Design and Oversight
372 February 11, 2014 Recruitment Status, Contacts/Locations, Study Status, Study Identification and Study Design
373 February 20, 2014 Contacts/Locations, Arms and Interventions and Study Status
374 August 12, 2014 Outcome Measures, Study Status and Study Design
375 August 26, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
376 September 3, 2014 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Status, Study Description, Study Identification, Eligibility and Study Design
377 March 17, 2015 Recruitment Status, Contacts/Locations, Study Status, Arms and Interventions and Study Identification
378 April 5, 2016 Study Status
379 August 19, 2016 Recruitment Status, Study Status and Contacts/Locations
380 August 29, 2017 Study Status and Contacts/Locations
381 July 11, 2018 Recruitment Status, Contacts/Locations, Study Status, Arms and Interventions, Study Identification, Study Description, Eligibility and Conditions
382 August 3, 2018 Oversight and Study Status
383 July 15, 2019 Recruitment Status, Contacts/Locations, Study Status, Oversight and Arms and Interventions
384 August 2, 2019 Oversight, Outcome Measures and Study Status
385 September 9, 2019 References and Study Status
386 November 14, 2019 Study Status, Study Design, Oversight, References, Contacts/Locations, Eligibility, Arms and Interventions and Conditions
387 February 12, 2020 Outcome Measures, Arms and Interventions, Oversight, Study Status and Study Identification
388 April 13, 2020 Outcome Measures, Oversight, Study Status, Contacts/Locations, Arms and Interventions and Study Identification
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Results Submission Events
389 July 24, 2020 Study Status, Outcome Measures, Document Section, Results and References
390 January 4, 2022 Study Status
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Study NCT00392327
Submitted Date:  October 25, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000511991
Brief Title: Chemotherapy and Radiation Therapy in Treating Young Patients Who Have Undergone Surgery for Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor
Official Title: Phase III Randomized Study of Standard Chemoradiotherapy With or Without Carboplatin Followed by Standard Maintenance Therapy With or Without Isotretinoin and Continuation Therapy With Isotretinoin Versus No Continuation Therapy in Pediatric Patients Who Have Undergone Surgery for Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor
Secondary IDs: COG-ACNS0332
Open or close this module Study Status
Record Verification: October 2006
Overall Status: Not yet recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: October 25, 2006
First Submitted that
Met QC Criteria:
October 25, 2006
First Posted: October 26, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 25, 2006
Last Update Posted: October 26, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Children's Oncology Group
Responsible Party:
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Isotretinoin may help chemotherapy work better by making tumor cells more sensitive to the drugs. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as carboplatin may make tumor cells more sensitive to radiation therapy. It is not yet known which regimen of chemotherapy when given together with radiation therapy is more effective for brain tumors.

PURPOSE: This randomized phase III trial is comparing two regimens of chemotherapy and radiation therapy in treating young patients who have undergone surgery for newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumor.

Detailed Description:

OBJECTIVES:

Primary

  • Determine whether carboplatin radiosensitization increases long-term, event-free survival of pediatric patients who have undergone surgery for newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumors.
  • Determine whether isotretinoin increases long-term, event-free survival of these patients.

Secondary

  • Compare residual disease response to radiotherapy alone versus radiotherapy and carboplatin in these patients.
  • Identify molecular prognostic indicators suitable for patient stratification in future trials.
  • Compare the health-related quality of life (HRQOL) of these patients during phases of active treatment specific to treatment modalities.
  • Compare the neuropsychological functioning of patients treated with these regimens and evaluate the relationship between neuropsychological status and HRQOL.

OUTLINE: This is a randomized, open label, factorial-designed, multicenter study. Patients are stratified according to location of disease and dissemination status (M0 medulloblastoma with > 1.5 cm² residual vs M+ medulloblastoma vs M0 supratentorial primitive neuroectodermal tumor [SPNET] with < 1.5 cm² residual vs M0 SPNET with > 1.5 cm² residual vs M+ SPNET. Patients are randomized* to 1 of 4 treatment arms.

NOTE: *Patients with a history of clinical depression are nonrandomly assigned to Arm I or II and do not receive isotretinoin.

  • Chemoradiotherapy: Within 31 days after surgery, patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40 and receive vincristine IV over 1 minute on days 1, 8, 15, 22, 29, and 36. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.
  • Maintenance therapy: Patients receive cisplatin IV over 6 hours on day 1, vincristine IV over 1 minute on days 1 and 8, and cyclophosphamide IV over 1 hour on days 2 and 3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 4 and continuing until blood counts recover (at least 10 days). Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
  • Chemoradiotherapy: Patients receive carboplatin IV over 15 minutes once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40 and undergo radiotherapy and receive vincristine as in arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.
  • Maintenance therapy: Patients receive maintenance therapy as in arm I.
  • Chemoradiotherapy: Patients undergo chemoradiotherapy, as in arm I. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.
  • Maintenance therapy: Patients receive oral isotretinoin twice daily on day 1 and then on days 16-28 and cisplatin, vincristine, cyclophosphamide, and G-CSF as in arm I maintenance therapy. Treatment repeats every 28 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to continuation therapy.
  • Continuation therapy: Patients receive oral isotretinoin twice daily on days 15-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Chemoradiotherapy: Patients undergo chemoradiotherapy as in arm II. Six weeks after completion of chemoradiotherapy, patients proceed to maintenance therapy.
  • Maintenance therapy: Patients receive maintenance therapy as in arm III. Patients then proceed to continuation therapy.
  • Continuation therapy: Patients receive continuation therapy as in arm III. Quality of life is assessed at baseline and periodically during study treatment (for patients ages 3 to 18). Neuropsychological evaluations are performed on all patients at baseline and at 2.5 to 3 years after completion of study treatment.

After completion of study treatment, patients are followed for up to 10 years.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Open or close this module Conditions
Conditions: Psychosocial Effects/Treatment
Cognitive/Functional Effects
Long-Term Effects Secondary to Cancer Therapy in Children
Radiation Toxicity
Untreated Childhood Medulloblastoma
Untreated Childhood Supratentorial Primitive Neuroectodermal Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: filgrastim
Drug: isotretinoin
Drug: vincristine
Procedure: adjuvant therapy
Procedure: biological therapy
Procedure: chemosensitization/potentiation
Procedure: chemotherapy
Procedure: cognitive assessment
Procedure: colony-stimulating factor therapy
Procedure: complications of therapy assessment/management
Procedure: conformal radiation therapy
Procedure: cytokine therapy
Procedure: psychosocial assessment/care
Procedure: quality-of-life assessment
Procedure: radiation therapy
Procedure: radiosensitization
Procedure: supportive care/therapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 3 Years
Maximum Age: 21 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET)
  • Newly diagnosed disease
  • Previously untreated disease
  • Meets 1 of the following criteria:
  • M0 medulloblastoma with > 1.5 cm² residual tumor
  • M+ medulloblastoma
  • M0 or M+ supratentorial PNET
  • Anaplastic medulloblastoma with any M-stage or residual tumor
  • Must have undergone stereotactic biopsy or attempted neurosurgical resection of the tumor within the past 31 days
  • The following procedures are required:
  • Pre-operative MRI of the brain with and without contrast
  • Post-operative (preferably within 72 hours after surgery) MRI of the brain with and without contrast**
  • Spinal MRI with and without contrast within 7 days before surgery or 28 days after surgery
  • Lumbar cerebrospinal fluid (CSF) cytological examination within 31 days after surgery*** NOTE: **Not required for patients with M2 or M3 disease or for patients who undergo stereotactic biopsy only

NOTE: ***If a spinal tap is contraindicated, and there is no ventricular CSF available, CSF cytology may be waived for patients with supratentorial tumors OR if there is documentation of spinal subarachnoid metastases (M3); patients with M1 disease must have either an intraoperative-positive CSF by lumbar puncture at the end of surgery OR a positive lumbar CSF obtained more than 7 days after surgery (to rule out surgically-induced false positives

  • No M4 disease

PATIENT CHARACTERISTICS:

  • Karnofsky/Lansky performance status 50-100%
  • Life expectancy > 8 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective forms of contraception
  • Creatinine normal OR creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min
  • Normal creatinine based on age/gender as follows:
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST and ALT < 2.5 times ULN (5 times ULN for patients on antiseizure medications)
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³ (transfusions not allowed)
  • Hemoglobin ≥ 8 g/dL (transfusions allowed)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy
  • No other concurrent experimental therapy
  • No concurrent isotretinoin for acne treatment
  • No concurrent corticosteroids as an antiemetic during chemotherapy
Open or close this module Contacts/Locations
Study Officials: James Olson, MD, PhD
Study Chair
Fred Hutchinson Cancer Center
Roger J. Packer, MD
Children's National Research Institute
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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