Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence

• Sponsor: ECOG-ACRIN Cancer Research Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01824823
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 3
• Locations: 272
• Arms: 2
• Actual Duration (Months): 88.7
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This randomized phase II trial studies how well giving afatinib after chemoradiation and surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and neck at high-risk of recurrence. Afatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Squamous Cell Carcinoma	Drug: afatinib; Other: placebo	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. Examine disease-free survival (DFS) given afatinib/placebo adjuvant therapy in patients with viable tumors in lymph nodes after neck dissection for suspected residual disease after concurrent chemoradiation.

SECONDARY OBJECTIVES:

1. Evaluate the recurrence rate, recurrence patterns, development of second primary malignancies, overall survival (OS) and toxicity of afatinib/placebo.

2. Evaluate on-target inhibition by afatinib, and determine circulating deoxyribonucleic acid (DNA) as a biomarker of afatinib resistance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive afatinib orally (PO) once daily (QD) on days 1-28.

ARM B: Patients receive placebo PO QD on days 1-28.

In both Arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year and then every 12 months for 2 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients With Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence
• Actual Study Start Date: Jul 11, 2013
• Actual Primary Completion Date: Dec 13, 2015
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A (afatinib) Patients receive afatinib PO QD on days 1-28.	Drug: afatinib; Given PO; Other Names: BIBW 2992
Placebo Comparator: Arm B (placebo) Patients receive placebo PO QD on days 1-28.	Other: placebo; Given PO

Outcome Measures

Primary Outcome Measures

1. Disease-free Survival (DFS) [Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration]

   DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Patients must have pathological evidence of persistent primary and/or lymph node disease with viable tumor cells following primary concurrent chemoradiotherapy of locoregionally advanced (stage III/IV) HNSCC of the oral cavity, oropharynx, larynx, hypopharynx or p16-positive unknown primary of the head and neck region; persistent primary and/or lymph node disease with viable tumor cells will be determined by the histological determination of tumor viability defined as tumor cells with intact cellular compartments (i.e. cytoplasm and nucleus) that do not exhibit karyolysis, pyknosis, or karyorrhexis on haematoxylin and eosin (H&E) staining

• Patients must have undergone a neck dissection following completion of chemoradiotherapy and must have involved at the minimum a compartment dissection of nodal levels with residual abnormalities on post-treatment imaging studies and/or received a complete resection of the residual primary lesion with negative margins

• Patients must have achieved a complete response at the primary disease site after chemoradiotherapy or complete resection of the residual primary site disease with negative margins

• All persistent lymph node disease must have received at least 66 Gy of radiotherapy and must have been completely surgically resected prior to registration, and surgical incisions should be adequately healed

• Patients with extracapsular lymph node extension, perineural or lymphovascular invasion will be eligible

• Patients must be at least 6 weeks (42 days) and no more than 36 weeks (252 days) from completion of chemoradiation at the time of registration

• Patients will be eligible regardless of ability to swallow; patients with dysphagia may have afatinib/placebo administered via gastrostomy tube

• Absolute neutrophil count >= 1,000/mm^3

• Platelets >= 100,000/mm^3

• Total bilirubin =< 1.5 x the upper limit of normal (ULN)

• Aspartate amino transferase (AST) =< 3 x the ULN

• Alanine amino transferase (ALT) =< 3 x the ULN

• Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula

• Prior cetuximab or any epidermal growth factor receptor (EGFR) inhibitors will not be permitted including cetuximab administered with a chemoradiotherapy or radiotherapy regimen

• As all patients in this study will have received prior full dose, curative-intent external-beam radiotherapy to the involved neck, no additional external-beam radiotherapy will be permitted prior to or during study participation

• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception

• Patients must have electrocardiogram (ECG) within 8 weeks prior to randomization to the study

• Patients must be assessed for cardiac function by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) within 8 weeks prior to randomization

Exclusion Criteria:

• Patients with known distant metastatic disease or with any gross residual disease following salvage primary tumor resection or neck dissection

• Known hypersensitivity to afatinib or any of the excipients of this product

• Prior adjuvant chemotherapy (aside from the initial induction chemotherapy followed by chemoradiotherapy or chemoradiotherapy regimen)

• History of acute myocardial infarction within 3 months prior to registration, and any history of uncontrolled angina, uncontrolled arrhythmia, or uncontrolled heart failure

• Pregnant or breast-feeding women

• Active infections, other cancers, or history of other cancers

• Participation in any other clinical trials or taking any other experimental medications

• Left ventricular dysfunction

• Evidence of interstitial lung disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alaska Breast Care and Surgery LLC	Anchorage	Alaska	United States	99508
2	Alaska Women's Cancer Care	Anchorage	Alaska	United States	99508
3	Anchorage Oncology Centre	Anchorage	Alaska	United States	99508
4	Katmai Oncology Group	Anchorage	Alaska	United States	99508
5	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
6	Veteran's Administration Medical Center	Little Rock	Arkansas	United States	72205
7	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
8	Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
9	Beebe Medical Center	Lewes	Delaware	United States	19958
10	Christiana Gynecologic Oncology LLC	Newark	Delaware	United States	19713
11	Delaware Clinical and Laboratory Physicians PA	Newark	Delaware	United States	19713
12	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
13	Medical Oncology Hematology Consultants PA	Newark	Delaware	United States	19713
14	Regional Hematology and Oncology PA	Newark	Delaware	United States	19713
15	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
16	Beebe Health Campus	Rehoboth Beach	Delaware	United States	19971
17	Nanticoke Memorial Hospital	Seaford	Delaware	United States	19973
18	Christiana Care Health System-Wilmington Hospital	Wilmington	Delaware	United States	19801
19	Emory University/Winship Cancer Institute	Atlanta	Georgia	United States	30322
20	Medical Center of Central Georgia	Macon	Georgia	United States	31208
21	Saint Alphonsus Cancer Care Center-Boise	Boise	Idaho	United States	83706
22	Kootenai Medical Center	Coeur d'Alene	Idaho	United States	83814
23	Saint Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
24	Kootenai Cancer Center	Post Falls	Idaho	United States	83854
25	Kootenai Cancer	Sandpoint	Idaho	United States	83864
26	Memorial Hospital of Carbondale	Carbondale	Illinois	United States	62902
27	Centralia Oncology Clinic	Centralia	Illinois	United States	62801
28	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612-3785
29	University of Illinois	Chicago	Illinois	United States	60612
30	Saint Joseph Hospital	Chicago	Illinois	United States	60657
31	Cancer Care Center of Decatur	Decatur	Illinois	United States	62526
32	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
33	Crossroads Cancer Center	Effingham	Illinois	United States	62401
34	Hinsdale Hematology Oncology Associates Incorporated	Hinsdale	Illinois	United States	60521
35	Garneau, Stewart C MD (UIA Investigator)	Moline	Illinois	United States	61265
36	Porubcin, Michael MD (UIA Investigator)	Moline	Illinois	United States	61265
37	Spector, David MD (UIA Investigator)	Moline	Illinois	United States	61265
38	Trinity Medical Center	Moline	Illinois	United States	61265
39	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
40	Memorial Medical Center	Springfield	Illinois	United States	62781-0001
41	Mary Greeley Medical Center	Ames	Iowa	United States	50010
42	McFarland Clinic PC-William R Bliss Cancer Center	Ames	Iowa	United States	50010
43	Constantinou, Costas L MD (UIA Investigator)	Bettendorf	Iowa	United States	52722
44	McFarland Clinic PC-Boone	Boone	Iowa	United States	50036
45	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa	United States	50325
46	Mercy Cancer Center-West Lakes	Clive	Iowa	United States	50325
47	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
48	Iowa Oncology Research Association CCOP	Des Moines	Iowa	United States	50309
49	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
50	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
51	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
52	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
53	McFarland Clinic PC-Trinity Cancer Center	Fort Dodge	Iowa	United States	50501
54	McFarland Clinic PC-Jefferson	Jefferson	Iowa	United States	50129
55	McFarland Clinic PC-Marshalltown	Marshalltown	Iowa	United States	50158
56	Siouxland Hematology Oncology Associates	Sioux City	Iowa	United States	51101
57	Mercy Medical Center-Sioux City	Sioux City	Iowa	United States	51104
58	Saint Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
59	Methodist West Hospital	West Des Moines	Iowa	United States	50266-7700
60	Mercy Medical Center-West Lakes	West Des Moines	Iowa	United States	50266
61	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
62	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
63	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
64	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
65	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
66	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
67	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
68	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67901
69	Cancer Center of Kansas-Manhattan	Manhattan	Kansas	United States	66502
70	Cancer Center of Kansas - McPherson	McPherson	Kansas	United States	67460
71	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
72	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
73	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
74	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
75	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
76	Associates In Womens Health	Wichita	Kansas	United States	67208
77	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
78	Cancer Center of Kansas - Main Office	Wichita	Kansas	United States	67214
79	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
80	Wichita CCOP	Wichita	Kansas	United States	67214
81	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
82	Harold Alfond Center for Cancer Care	Augusta	Maine	United States	04330
83	Eastern Maine Medical Center	Bangor	Maine	United States	04401
84	Penobscot Bay Medical Center	Rockport	Maine	United States	04856
85	Greater Baltimore Medical Center	Baltimore	Maryland	United States	21204
86	Bixby Medical Center	Adrian	Michigan	United States	49221
87	Hickman Cancer Center	Adrian	Michigan	United States	49221
88	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
89	Michigan Cancer Research Consortium Community Clinical Oncology Program	Ann Arbor	Michigan	United States	48106
90	Bronson Battle Creek	Battle Creek	Michigan	United States	49017
91	Spectrum Health Big Rapids Hospital	Big Rapids	Michigan	United States	49307
92	Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48124
93	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
94	Hurley Medical Center	Flint	Michigan	United States	48502
95	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
96	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan	United States	49503
97	Mercy Health Saint Mary's	Grand Rapids	Michigan	United States	49503
98	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan	United States	49503
99	Allegiance Health	Jackson	Michigan	United States	49201
100	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
101	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
102	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
103	Sparrow Hospital	Lansing	Michigan	United States	48912
104	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
105	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
106	Mercy Memorial Hospital	Monroe	Michigan	United States	48162
107	Mercy Health Mercy Campus	Muskegon	Michigan	United States	49444
108	Lakeland Community Hospital	Niles	Michigan	United States	49120
109	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
110	Saint Joseph Mercy Port Huron	Port Huron	Michigan	United States	48060
111	Spectrum Health Reed City Hospital	Reed City	Michigan	United States	49677
112	Saint Mary's of Michigan	Saginaw	Michigan	United States	48601
113	Lakeland Hospital	Saint Joseph	Michigan	United States	49085
114	Marie Yeager Cancer Center	Saint Joseph	Michigan	United States	49085
115	Munson Medical Center	Traverse City	Michigan	United States	49684
116	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
117	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
118	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
119	Fairview-Southdale Hospital	Edina	Minnesota	United States	55435
120	Unity Hospital	Fridley	Minnesota	United States	55432
121	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
122	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota	United States	55109
123	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
124	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
125	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
126	Health Partners Inc	Minneapolis	Minnesota	United States	55454
127	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
128	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
129	Metro-Minnesota CCOP	Saint Louis Park	Minnesota	United States	55416
130	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
131	Regions Hospital	Saint Paul	Minnesota	United States	55101
132	United Hospital	Saint Paul	Minnesota	United States	55102
133	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
134	Lakeview Hospital	Stillwater	Minnesota	United States	55082
135	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
136	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
137	Minnesota Oncology and Hematology PA-Woodbury	Woodbury	Minnesota	United States	55125
138	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
139	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
140	Phelps County Regional Medical Center	Rolla	Missouri	United States	65401
141	Saint John's Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
142	Saint John's Mercy Medical Center	Saint Louis	Missouri	United States	63141
143	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
144	Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield	Springfield	Missouri	United States	65804
145	CoxHealth South Hospital	Springfield	Missouri	United States	65807
146	Montana Cancer Consortium CCOP	Billings	Montana	United States	59101
147	Saint Vincent Healthcare	Billings	Montana	United States	59101
148	Billings Clinic	Billings	Montana	United States	59107-7000
149	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
150	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
151	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
152	Saint Peter's Community Hospital	Helena	Montana	United States	59601
153	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
154	Community Medical Hospital	Missoula	Montana	United States	59801
155	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
156	Nebraska Hematology and Oncology	Lincoln	Nebraska	United States	68506
157	Nebraska Cancer Research Center	Lincoln	Nebraska	United States	68510
158	Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
159	Nebraska Methodist Hospital	Omaha	Nebraska	United States	68114
160	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
161	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
162	Oncology Hematology West	Omaha	Nebraska	United States	68124
163	Alegent Health Lakeside Hospital	Omaha	Nebraska	United States	68130
164	Oncology Hematology West PC	Omaha	Nebraska	United States	68130
165	Urology Cancer Center PC	Omaha	Nebraska	United States	68130
166	Creighton University Medical Center	Omaha	Nebraska	United States	68131
167	New York Oncology Hematology PC - Albany	Albany	New York	United States	12206
168	New York Oncology Hematology PC -Albany Medical Center	Albany	New York	United States	12208
169	Albert Einstein College of Medicine	Bronx	New York	United States	10461
170	Montefiore Medical Center-Einstein Campus	Bronx	New York	United States	10461
171	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467-2490
172	New York Oncology Hematology PC-Hudson	Hudson	New York	United States	12534
173	New York Oncology Hematology PC - Latham	Latham	New York	United States	12110
174	Orange Regional Medical Center	Middletown	New York	United States	10940
175	New York Oncology Hematology PC - Troy	Troy	New York	United States	12180
176	Randolph Hospital	Asheboro	North Carolina	United States	27203
177	Southeastern Medical Oncology Center-Clinton	Clinton	North Carolina	United States	28328
178	Southeastern Medical Oncology Center-Goldsboro	Goldsboro	North Carolina	United States	27534
179	Wayne Memorial Hospital	Goldsboro	North Carolina	United States	27534
180	Cone Health Cancer Center	Greensboro	North Carolina	United States	27403
181	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
182	Southeastern Medical Oncology Center-Jacksonville	Jacksonville	North Carolina	United States	28546
183	Kinston Medical Specialists PA	Kinston	North Carolina	United States	28501
184	Annie Penn Memorial Hospital	Reidsville	North Carolina	United States	27320
185	Southeastern Medical Oncology Center-Wilson	Wilson	North Carolina	United States	27893
186	Akron General Medical Center	Akron	Ohio	United States	44307
187	Toledo Clinic Cancer Centers-Bowling Green	Bowling Green	Ohio	United States	43402
188	University of Cincinnati	Cincinnati	Ohio	United States	45267
189	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
190	Saint Rita's Medical Center	Lima	Ohio	United States	45801
191	Lima Memorial Hospital	Lima	Ohio	United States	45804
192	Toledo Clinic Cancer Centers-Maumee	Maumee	Ohio	United States	43537
193	Toledo Radiation Oncology at Northwest Ohio Onocolgy Center	Maumee	Ohio	United States	43537
194	Saint Charles Hospital	Oregon	Ohio	United States	43616
195	Toledo Clinic Cancer Centers-Oregon	Oregon	Ohio	United States	43616
196	Flower Hospital	Sylvania	Ohio	United States	43560
197	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
198	The Toledo Hospital/Toledo Children's Hospital	Toledo	Ohio	United States	43606
199	Saint Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
200	University of Toledo	Toledo	Ohio	United States	43614
201	Toledo Community Hospital Oncology Program CCOP	Toledo	Ohio	United States	43617
202	Mercy Saint Anne Hospital	Toledo	Ohio	United States	43623
203	Toledo Clinic Cancer Centers-Toledo	Toledo	Ohio	United States	43623
204	Fulton County Health Center	Wauseon	Ohio	United States	43567
205	University Pointe	West Chester	Ohio	United States	45069
206	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
207	Tulsa Cancer Institute	Tulsa	Oklahoma	United States	74146
208	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
209	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
210	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
211	Providence Willamette Falls Medical Center	Oregon City	Oregon	United States	97045
212	Providence Portland Medical Center	Portland	Oregon	United States	97213
213	Western Oncology Research Consortium	Portland	Oregon	United States	97213
214	Providence Saint Vincent Medical Center	Portland	Oregon	United States	97225
215	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
216	Adams Cancer Center	Gettysburg	Pennsylvania	United States	17325
217	Cherry Tree Cancer Center	Hanover	Pennsylvania	United States	17331
218	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania	United States	18201
219	Geisinger Medical Oncology at Evangelical Community Hospital	Lewisburg	Pennsylvania	United States	17837
220	Lewistown Hospital	Lewistown	Pennsylvania	United States	17044
221	Pottstown Memorial Medical Center	Pottstown	Pennsylvania	United States	19464
222	Geisinger Medical Oncology-Pottsville	Pottsville	Pennsylvania	United States	17901
223	Geisinger Medical Group	State College	Pennsylvania	United States	16801
224	Geisinger Wyoming Valley	Wilkes-Barre	Pennsylvania	United States	18711
225	WellSpan Health-York Hospital	York	Pennsylvania	United States	17405
226	Greenville Health System Cancer Institute-Easley	Easley	South Carolina	United States	29640
227	Greenville Health System Cancer Institute-Andrews	Greenville	South Carolina	United States	29605
228	Greenville Health System Cancer Institute-Butternut	Greenville	South Carolina	United States	29605
229	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina	United States	29605
230	Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
231	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina	United States	29615
232	Greenville Health System Cancer Institute-Greer	Greer	South Carolina	United States	29650
233	Greenville Health System Cancer Institute-Seneca	Seneca	South Carolina	United States	29672
234	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina	United States	29307
235	Wellmont Bristol Regional Medical Center	Bristol	Tennessee	United States	37620
236	Wellmont Medical Associates Oncology and Hematology-Johnson City	Johnson City	Tennessee	United States	37604
237	Wellmont Holston Valley Hospital and Medical Center	Kingsport	Tennessee	United States	37660
238	Wellmont Medical Associates Oncology and Hematology-Kingsport	Kingsport	Tennessee	United States	37660
239	Thompson Cancer Survival Center	Knoxville	Tennessee	United States	37916
240	Meharry Medical College	Nashville	Tennessee	United States	37208
241	University Medical Center Brackenridge	Austin	Texas	United States	78701
242	Fredericksburg Oncology Inc	Fredericksburg	Virginia	United States	22401
243	Southwest VA Regional Cancer Center	Norton	Virginia	United States	24273
244	Auburn Regional Medical Center	Auburn	Washington	United States	98001
245	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004
246	Providence Regional Cancer System-Centralia	Centralia	Washington	United States	98531
247	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
248	Saint Francis Hospital	Federal Way	Washington	United States	98003
249	Providence Regional Cancer System-Lacey	Lacey	Washington	United States	98503
250	Saint Clare Hospital	Lakewood	Washington	United States	98499
251	Saint John Medical Center	Longview	Washington	United States	98632
252	Providence - Saint Peter Hospital	Olympia	Washington	United States	98506-5166
253	Capital Medical Center	Olympia	Washington	United States	98507
254	Good Samaritan Community Hospital	Puyallup	Washington	United States	98372
255	Allenmore Hospital	Tacoma	Washington	United States	98405
256	Northwest CCOP	Tacoma	Washington	United States	98405
257	Northwest Medical Specialties PLLC	Tacoma	Washington	United States	98405
258	Saint Joseph Medical Center	Tacoma	Washington	United States	98405
259	Multicare Health System	Tacoma	Washington	United States	98415
260	PeaceHealth Southwest Medical Center	Vancouver	Washington	United States	98664
261	West Virginia University Charleston	Charleston	West Virginia	United States	25304
262	West Virginia University Healthcare	Morgantown	West Virginia	United States	26506
263	Langlade Hospital and Cancer Center	Antigo	Wisconsin	United States	54409
264	Gundersen Lutheran Medical Center	La Crosse	Wisconsin	United States	54601
265	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
266	Cancer Center of Western Wisconsin	New Richmond	Wisconsin	United States	54017
267	Aspirus Regional Cancer Center	Wausau	Wisconsin	United States	54401
268	Riverview Hospital	Wisconsin Rapids	Wisconsin	United States	54494
269	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
270	Big Horn Basin Cancer Center	Cody	Wyoming	United States	82414
271	Billings Clinic-Cody	Cody	Wyoming	United States	82414
272	Welch Cancer Center	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• ECOG-ACRIN Cancer Research Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Christine Chung, Eastern Cooperative Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ECOG-ACRIN Cancer Research Group
• ClinicalTrials.gov Identifier: NCT01824823
• Other Study ID Numbers: E1311; NCI-2013-00357; U10CA021115
• First Posted: Apr 5, 2013
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by ECOG-ACRIN Cancer Research Group: afatinib; head and neck squamous cell carcinoma
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Recurrence; Afatinib

Study Results

Participant Flow

Arm/Group Title	Arm A (Afatinib)	Arm B (Placebo)
Arm/Group Description	Patients receive afatinib PO QD on days 1-28.	Patients receive placebo PO QD on days 1-28.
Period Title: Overall Study
STARTED	2	1
COMPLETED	0	0
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Arm A (Afatinib)	Arm B (Placebo)	Total
Arm/Group Description	Patients receive afatinib PO QD on days 1-28.	Patients receive placebo PO QD on days 1-28.	Total of all reporting groups
Overall Participants	2	1	3
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	0 0%	2 66.7%
>=65 years	0 0%	1 100%	1 33.3%
Sex: Female, Male (Count of Participants)
Female	1 50%	0 0%	1 33.3%
Male	1 50%	1 100%	2 66.7%

Outcome Measures

1. Primary Outcome

Title	Disease-free Survival (DFS)
Description	DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.
Time Frame	Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration

Outcome Measure Data

Analysis Population Description

All randomized patients

Arm/Group Title	Arm A (Afatinib)	Arm B (Placebo)
Arm/Group Description	Patients receive afatinib PO QD on days 1-28.	Patients receive placebo PO QD on days 1-28.
Measure Participants	2	1
Median (95% Confidence Interval) [months]	NA	NA

Adverse Events

Time Frame	Assessed every 4 weeks while on treatment and for 30 days after the end of treatment.
Arm/Group Title	Arm A (Afatinib)		Arm B (Placebo)
Arm/Group Description	Patients receive afatinib PO QD on days 1-28.		Patients receive placebo PO QD on days 1-28.
All Cause Mortality
	Arm A (Afatinib)		Arm B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A (Afatinib)		Arm B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		1/1 (100%)
Gastrointestinal disorders
Diarrhea	1/2 (50%)		0/1 (0%)
Psychiatric disorders
Confusion	0/2 (0%)		1/1 (100%)
Skin and subcutaneous tissue disorders
Rash acneiform	1/2 (50%)		0/1 (0%)
Rash maculo-papular	1/2 (50%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Arm A (Afatinib)		Arm B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		0/1 (0%)
Blood and lymphatic system disorders
Anemia	1/2 (50%)		0/1 (0%)
Endocrine disorders
Hyperthyroidism	1/2 (50%)		0/1 (0%)
Gastrointestinal disorders
Diarrhea	2/2 (100%)		0/1 (0%)
Mucositis oral	2/2 (100%)		0/1 (0%)
Investigations
Lymphocyte count decreased	1/2 (50%)		0/1 (0%)
White blood cell decreased	1/2 (50%)		0/1 (0%)
Metabolism and nutrition disorders
Hyperglycemia	1/2 (50%)		0/1 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify	1/2 (50%)		0/1 (0%)
Spasticity	1/2 (50%)		0/1 (0%)
Skin and subcutaneous tissue disorders
Dry skin	1/2 (50%)		0/1 (0%)
Rash acneiform	2/2 (100%)		0/1 (0%)
Skin and subcutaneous tissue disorders - Other, specify	1/2 (50%)		0/1 (0%)

Limitations/Caveats

Due to the small sample size, estimates on median DFS and 95% confidence intervals could be unreliable.

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.