S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00789958
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 105
• Locations: 251
• Arm: 1
• Duration (Months): 108
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct.

Condition or Disease	Intervention/Treatment	Phase
Extrahepatic Bile Duct Cancer; Gallbladder Cancer	Drug: capecitabine; Drug: gemcitabine hydrochloride; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

• To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy comprising capecitabine and gemcitabine hydrochloride, followed by capecitabine and radiotherapy. (R0 stratum closed as of 12-15-11)

• To estimate the 2-year stratum-specific and overall disease-free survival and local disease-free survival of patients treated with this regimen.

• To assess the frequency and severity of toxicity in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to margin of resection (negative [R0] vs microscopically positive [R1]). (R0 stratum closed as of 12-15-11)

• Adjuvant chemotherapy: Patients receive oral capecitabine every 12 hours on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

• Chemoradiotherapy: Beginning in week 13, patients receive oral capecitabine every 12 hours on days 1-7. Patients also undergo concurrent three-dimensional or intensity-modulated radiotherapy on days 1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy patients are followed periodically for up to 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed By Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Adjuvant Chemo+ Chemoradiotherapy Adjuvant Chemotherapy Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle Chemoradiotherapy -Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions. intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.

Drug: capecitabine; Adjuvant chemotherapy: 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle Chemoradiotherapy: 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Other Names: Xeloda NSC-712807 ; Drug: gemcitabine hydrochloride; 1000 mg/m^2, IV, Days 1 & 8 of each cycle; Other Names: Gemzar NSC-619927 ; Radiation: 3-dimensional conformal radiation therapy; 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions.; Other Names: 3D radiotherapy ; Radiation: intensity-modulated radiation therapy; 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.; Other Names: IMRT

Outcome Measures

Primary Outcome Measures

1. Stratum-specific (R0 and R1) 2-year Overall Survival [Up to 2 years from registration]

   Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Secondary Outcome Measures

1. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [Up to 5 years]

   Only adverse events that are possibly, probably or definitely related to study drug are reported.

2. 2-year Overall Survival for All Patients [Up to 2 years from registration]

   Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

3. 2-year Stratum-specific Disease-free Survival [Up to 2 years from registration]

   Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.

4. 2-year Disease-free Survival in All Patients [Up to 2 years from registration]

   Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.

5. 2-year Stratum-specific Local Relapse Rate [Up to 2 years from registration]

   Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).

6. 2-year Overall Local Relapse Rate [Up to 2 years from registration]

   Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or bile duct, meeting at least 1 of the following criteria:

• Pathological T2-4 disease

• Pathological N1 disease

• Positive margins (any T or N )

• Must have undergone potentially curative radical resection with negative (R0) or microscopically positive (R1) margins within the past 56 days and recovered (R0 stratum closed as of 12-15-11)

• No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen, and pelvis within the past 42 days

• Positive resected regional lymph nodes allowed

• No ampullary cancer

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• ANC > 1,500/μL

• Platelet count > 100,000/μL

• Serum creatinine < 1.5 mg/dL

• Total bilirubin < 1.5 times upper limit of normal (ULN)

• SGOT or SGPT < 2.5 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Able to swallow enteral medications and no requirement for a feeding tube

• No intractable nausea or vomiting

• No gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, requirement for IV alimentation, prior surgical procedures affecting absorptions. or uncontrolled inflammatory GI disease (e.g., Crohn disease, ulcerative colitis)

• No uncontrolled intercurrent illness including but not limited to any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Myocardial infarction or cerebrovascular accident within the past 3 months

• Uncontrolled diarrhea

• Psychiatric illness or social situations that would limit compliance with study requirements

• No prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy or radiotherapy for this disease

• No prior upper abdominal radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Medical Center	Anniston	Alabama	United States	36207
2	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California	United States	94704
4	Peninsula Medical Center	Burlingame	California	United States	94010
5	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
6	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California	United States	90027
7	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
8	Sutter Health - Western Division Cancer Research Group	Novato	California	United States	94945
9	Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center	Orange	California	United States	92868
10	California Pacific Medical Center - California Campus	San Francisco	California	United States	94118
11	Sutter Pacific Medical Foundation	Santa Rosa	California	United States	95403
12	Sutter Solano Medical Center	Vallejo	California	United States	94589
13	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
14	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
15	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
16	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
17	St. Anthony Central Hospital	Denver	Colorado	United States	80204
18	Porter Adventist Hospital	Denver	Colorado	United States	80210
19	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
20	St. Joseph Hospital	Denver	Colorado	United States	80218
21	Rose Medical Center	Denver	Colorado	United States	80220
22	CCOP - Colorado Cancer Research Program	Denver	Colorado	United States	80224-2522
23	Shaw Regional Cancer Center	Edwards	Colorado	United States	81632
24	Swedish Medical Center	Englewood	Colorado	United States	80110
25	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
26	North Colorado Medical Center	Greeley	Colorado	United States	80631
27	Littleton Adventist Hospital	Littleton	Colorado	United States	80122
28	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
29	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80501
30	McKee Medical Center	Loveland	Colorado	United States	80539
31	Parker Adventist Hospital	Parker	Colorado	United States	80138
32	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
33	Exempla Lutheran Medical Center	Wheat Ridge	Colorado	United States	80033
34	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware	United States	19958
35	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
36	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
37	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia	United States	20010
38	Piedmont Hospital	Atlanta	Georgia	United States	30309
39	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342-1611
40	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342-1701
41	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
42	WellStar Cobb Hospital	Austell	Georgia	United States	30106
43	John B. Amos Cancer Center	Columbus	Georgia	United States	31904
44	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
45	Piedmont Fayette Hospital	Fayetteville	Georgia	United States	30214
46	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
47	Medical Center of Central Georgia	Macon	Georgia	United States	31208
48	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
49	Southern Regional Medical Center	Riverdale	Georgia	United States	30274-2600
50	Harbin Clinic Cancer Center - Medical Oncology	Rome	Georgia	United States	30165
51	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
52	Hematology and Oncology Associates	Chicago	Illinois	United States	60611
53	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
54	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
55	Kellogg Cancer Care Center	Highland Park	Illinois	United States	60035
56	Provena St. Mary's Regional Cancer Center - Kankakee	Kankakee	Illinois	United States	60901
57	North Shore Oncology and Hematology Associates, Limited - Libertyville	Libertyville	Illinois	United States	60048
58	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
59	Edward Hospital Cancer Center	Naperville	Illinois	United States	60540
60	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois	United States	60714
61	Hematology Oncology Associates - Skokie	Skokie	Illinois	United States	60076
62	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
63	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
64	Medical Oncology and Hematology Associates - West Des Moines	Clive	Iowa	United States	50325
65	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
66	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
67	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
68	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
69	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
70	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
71	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
72	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51102
73	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
74	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
75	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
76	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
77	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
78	St. Rose Ambulatory and Surgery Center	Great Bend	Kansas	United States	67530
79	Hays Medical Center	Hays	Kansas	United States	67601
80	Hutchinson Hospital Corporation	Hutchinson	Kansas	United States	67502
81	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
82	Kansas City Cancer Centers - West	Kansas City	Kansas	United States	66112
83	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
84	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
85	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
86	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67901
87	Cancer Center of Kansas, PA - McPherson	McPherson	Kansas	United States	67460
88	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
89	Kansas City Cancer Centers - Southwest	Overland Park	Kansas	United States	66210
90	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
91	Mount Carmel Regional Cancer Center	Pittsburg	Kansas	United States	66762
92	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
93	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
94	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas	United States	67401
95	Kansas City Cancer Center - Shawnee Mission	Shawnee Mission	Kansas	United States	66204
96	St. Francis Comprehensive Cancer Center	Topeka	Kansas	United States	66606
97	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
98	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
99	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
100	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
101	CCOP - Wichita	Wichita	Kansas	United States	67214
102	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
103	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
104	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
105	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
106	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
107	Union Hospital of Cecil County	Elkton	Maryland	United States	21921
108	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
109	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts	United States	01805
110	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
111	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
112	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
113	Borgess Medical Center	Kalamazoo	Michigan	United States	49001
114	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007-3731
115	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
116	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
117	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
118	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
119	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
120	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
121	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
122	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
123	Minnesota Oncology - Maplewood	Maplewood	Minnesota	United States	55109
124	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
125	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
126	New Ulm Medical Center	New Ulm	Minnesota	United States	56073
127	Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota	United States	55422-2900
128	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
129	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
130	Park Nicollet Cancer Center	Saint Louis Park	Minnesota	United States	55416
131	Regions Hospital Cancer Care Center	Saint Paul	Minnesota	United States	55101
132	United Hospital	Saint Paul	Minnesota	United States	55102
133	St. Francis Cancer Center at St. Francis 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	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota	United States	56201
137	Minnesota Oncology - Woodbury	Woodbury	Minnesota	United States	55125
138	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
139	Truman Medical Center - Hospital Hill	Kansas City	Missouri	United States	64108
140	Kansas City Cancer Centers - South	Kansas City	Missouri	United States	64131
141	Kansas City Cancer Centers - North	Kansas City	Missouri	United States	64154
142	Kansas City Cancer Centers - East	Lee's Summit	Missouri	United States	64064
143	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
144	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
145	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
146	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
147	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
148	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
149	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
150	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
151	St. Peter's Hospital	Helena	Montana	United States	59601
152	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
153	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
154	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
155	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
156	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
157	Memorial Sloan-Kettering Cancer Center - Basking Ridge	Basking Ridge	New Jersey	United States	07920
158	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey	United States	08053
159	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey	United States	08043
160	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey	United States	08043
161	Memorial Sloan-Kettering Cancer Center	Commack	New York	United States	11725
162	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York	United States	13057
163	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
164	Memorial Sloan-Kettering Cancer Center - Rockville Centre	Rockville Centre	New York	United States	11570
165	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center	Sleepy Hollow	New York	United States	10591
166	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
167	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
168	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
169	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
170	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
171	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
172	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
173	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
174	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio	United States	44309-2090
175	Barberton Citizens Hospital	Barberton	Ohio	United States	44203
176	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
177	Grandview Hospital	Dayton	Ohio	United States	45405
178	Good Samaritan Hospital	Dayton	Ohio	United States	45406
179	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
180	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
181	CCOP - Dayton	Dayton	Ohio	United States	45420
182	Community Cancer Center	Elyria	Ohio	United States	44035
183	Hematology Oncology Center	Elyria	Ohio	United States	44035
184	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
185	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
186	Wayne Hospital	Greenville	Ohio	United States	45331
187	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
188	Lima Memorial Hospital	Lima	Ohio	United States	45804
189	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
190	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
191	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
192	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
193	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
194	Toledo Hospital	Toledo	Ohio	United States	43606
195	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
196	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
197	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
198	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
199	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
200	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
201	Fulton County Health Center	Wauseon	Ohio	United States	43567
202	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
203	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma	United States	74136
204	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
205	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
206	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
207	Willamette Falls Hospital	Oregon City	Oregon	United States	97045
208	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
209	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
210	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
211	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
212	UPMC Cancer Centers	Pittsburgh	Pennsylvania	United States	15232
213	AnMed Cancer Center	Anderson	South Carolina	United States	29621
214	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
215	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
216	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
217	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
218	American Fork Hospital	American Fork	Utah	United States	84003
219	Sandra L. Maxwell Cancer Center	Cedar City	Utah	United States	84720
220	Logan Regional Hospital	Logan	Utah	United States	84321
221	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
222	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
223	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
224	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
225	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
226	LDS Hospital	Salt Lake City	Utah	United States	84143
227	Danville Regional Medical Center	Danville	Virginia	United States	24541
228	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
229	Lynchburg Hematology-Oncology Clinic	Lynchburg	Virginia	United States	24501
230	Island Hospital Cancer Care Center at Island Hospital	Anacortes	Washington	United States	98221
231	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
232	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
233	Highline Medical Center Cancer Center	Burien	Washington	United States	98166
234	Swedish Medical Center - Issaquah Campus	Issaquah	Washington	United States	98029
235	Columbia Basin Hematology	Kennewick	Washington	United States	99336
236	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington	United States	98274
237	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington	United States	98370
238	Harborview Medical Center	Seattle	Washington	United States	98104
239	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
240	Group Health Central Hospital	Seattle	Washington	United States	98112
241	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
242	Polyclinic First Hill	Seattle	Washington	United States	98122
243	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
244	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington	United States	98284
245	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
246	Evergreen Hematology and Oncology, PS	Spokane	Washington	United States	99218
247	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98664
248	Northwest Cancer Specialists at Vancouver Cancer Center	Vancouver	Washington	United States	98684
249	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
250	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
251	Rocky Mountain Oncology	Casper	Wyoming	United States	82609

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Edgar Ben-Josef, MD, Barbara Ann Karmanos Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT00789958
• Other Study ID Numbers: S0809; S0809; U10CA032102; NCI-2009-00801
• First Posted: Nov 13, 2008
• Last Update Posted: Apr 9, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Southwest Oncology Group: cholangiocarcinoma of the extrahepatic bile duct; cholangiocarcinoma of the gallbladder; localized extrahepatic bile duct cancer; localized gallbladder cancer; unresectable extrahepatic bile duct cancer; unresectable gallbladder cancer; metastatic extrahepatic bile duct cancer; metastatic gallbladder cancer
• Additional relevant MeSH terms: Cholangiocarcinoma; Gallbladder Neoplasms; Bile Duct Neoplasms; Gemcitabine; Capecitabine

Study Results

Participant Flow

Arm/Group Title	Adjuvant Chemotherapy + Chemoradiotherapy
Arm/Group Description	Adjuvant Chemotherapy: Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
Period Title: Overall Study
STARTED	105
Eligible and Analyzable	79
COMPLETED	68
NOT COMPLETED	37

Baseline Characteristics

Arm/Group Title	Adjuvant Chemotherapy + Chemoradiotherapy
Arm/Group Description	Adjuvant Chemotherapy: Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
Overall Participants	79
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	41 51.9%
Male	38 48.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 6.3%
Not Hispanic or Latino	66 83.5%
Unknown or Not Reported	8 10.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 5.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 8.9%
White	66 83.5%
More than one race	0 0%
Unknown or Not Reported	2 2.5%
Margin of Resection (participants) [Number]
Negative (R0)	54 68.4%
Microscopically positive (R1)	25 31.6%

Outcome Measures

1. Primary Outcome

Title	Stratum-specific (R0 and R1) 2-year Overall Survival
Description	Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame	Up to 2 years from registration

Outcome Measure Data

Analysis Population Description

Eligible and analyzable patients that received protocol treatment.

Arm/Group Title	Patients With Negative Margins of Resection (R0)	Patients w/Microscopically Positive Margin of Resection (R1)
Arm/Group Description	Eligible and analyzable patients that received a resection with negative (R0) margins.	Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
Measure Participants	54	25
Number (95% Confidence Interval) [percentage of participants]	67 84.8%	60 NaN

2. Secondary Outcome

Title	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Description	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

Eligible patients who received any treatment and were assessed for adverse events are included in this summary.

Arm/Group Title	Adjuvant Chemotherapy + Chemoradiotherapy
Arm/Group Description	Adjuvant Chemotherapy: Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
Measure Participants	79
Anorexia	1 1.3%
Cardiac troponin I (cTnI)	1 1.3%
Constipation	1 1.3%
Dehydration	1 1.3%
Diarrhea	6 7.6%
Fatigue (asthenia, lethargy, malaise)	4 5.1%
Febrile neutropenia	1 1.3%
Hemoglobin	1 1.3%
Hemorrhage, GI - Duodenum	1 1.3%
Hemorrhage, GI - Lower GI NOS	1 1.3%
Hypotension	1 1.3%
Lung Infection w/normal ANC or Gr 1-2 neutrophils	1 1.3%
Skin Infection w/normal ANC or Gr 1-2 neutrophils	1 1.3%
Infection-Other (Specify)	1 1.3%
Leukocytes (total WBC)	5 6.3%
Lymphopenia	6 7.6%
Mucositis/stomatitis (clinical exam) - Oral cavity	2 2.5%
Neuropathy: sensory	1 1.3%
Neutrophils/granulocytes (ANC/AGC)	35 44.3%
Phosphate, serum-low (hypophosphatemia)	1 1.3%
Platelets	2 2.5%
Potassium, serum-low (hypokalemia)	2 2.5%
Rash/desquamation	1 1.3%
Rash: hand-foot skin reaction	10 12.7%
Sodium, serum-low (hyponatremia)	1 1.3%
Syncope (fainting)	1 1.3%
Thrombosis/embolism (vascular access-related)	1 1.3%
Thrombosis/thrombus/embolism	1 1.3%
Ulcer, GI - Duodenum	1 1.3%
Ventricular arrhythmia - Ventricular tachycardia	1 1.3%

3. Secondary Outcome

Title	2-year Overall Survival for All Patients
Description	Time to death is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame	Up to 2 years from registration

Outcome Measure Data

Analysis Population Description

Eligible and analyzable patients that received protocol treatment.

Arm/Group Title	Adjuvant Chemotherapy + Chemoradiotherapy
Arm/Group Description	Adjuvant Chemotherapy: Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
Measure Participants	79
Number (95% Confidence Interval) [percentage of participants]	65 82.3%

4. Secondary Outcome

Title	2-year Stratum-specific Disease-free Survival
Description	Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame	Up to 2 years from registration

Outcome Measure Data

Analysis Population Description

Eligible and analyzable patients that received protocol treatment.

Arm/Group Title	Patients With Negative Margins of Resection (R0)	Patients w/Microscopically Positive Margin of Resection (R1)
Arm/Group Description	Eligible and analyzable patients that received a resection with negative (R0) margins.	Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
Measure Participants	54	25
Number (95% Confidence Interval) [percentage of participants]	54 68.4%	48 NaN

5. Secondary Outcome

Title	2-year Disease-free Survival in All Patients
Description	Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame	Up to 2 years from registration

Outcome Measure Data

Analysis Population Description

Eligible and analyzable patients that received protocol treatment.

Arm/Group Title	Adjuvant Chemotherapy + Chemoradiotherapy
Arm/Group Description	Adjuvant Chemotherapy: Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
Measure Participants	79
Number (95% Confidence Interval) [percentage of participants]	52 65.8%

6. Secondary Outcome

Title	2-year Stratum-specific Local Relapse Rate
Description	Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
Time Frame	Up to 2 years from registration

Outcome Measure Data

Analysis Population Description

Eligible and analyzable patients that received protocol treatment.

Arm/Group Title	Patients With Negative Margins of Resection (R0)	Patients w/Microscopically Positive Margin of Resection (R1)
Arm/Group Description	Eligible and analyzable patients that received a resection with negative (R0) margins.	Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
Measure Participants	54	25
Number (95% Confidence Interval) [percentage of participants]	9 11.4%	16 NaN

7. Secondary Outcome

Title	2-year Overall Local Relapse Rate
Description	Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
Time Frame	Up to 2 years from registration

Outcome Measure Data

Analysis Population Description

Eligible and analyzable patients that received protocol treatment.

Arm/Group Title	Adjuvant Chemotherapy + Chemoradiotherapy
Arm/Group Description	Adjuvant Chemotherapy: Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
Measure Participants	79
Number (95% Confidence Interval) [percentage of participants]	11 13.9%

Adverse Events

Time Frame	Up to 5 years
Adverse Event Reporting Description	Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
Arm/Group Title	Adjuvant Chemotherapy + Chemoradiotherapy
Arm/Group Description	Adjuvant Chemotherapy: Capecitabine, 1500 mg/m^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m^2, IV, Days 1 & 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
All Cause Mortality
	Adjuvant Chemotherapy + Chemoradiotherapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Adjuvant Chemotherapy + Chemoradiotherapy
	Affected / at Risk (%)	# Events
Total	2/79 (2.5%)
Cardiac disorders
Ventricular arrhythmia - Ventricular tachycardia	1/79 (1.3%)
Gastrointestinal disorders
Hemorrhage, GI - Duodenum	1/79 (1.3%)
Ulcer, GI - Duodenum	1/79 (1.3%)
Investigations
Thrombocytopenia	1/79 (1.3%)
Other (Not Including Serious) Adverse Events
	Adjuvant Chemotherapy + Chemoradiotherapy
	Affected / at Risk (%)	# Events
Total	78/79 (98.7%)
Blood and lymphatic system disorders
Low hemoglobin level	45/79 (57%)
Gastrointestinal disorders
Constipation	24/79 (30.4%)
Diarrhea	35/79 (44.3%)
Distention/bloating, abdominal	8/79 (10.1%)
Flatulence	4/79 (5.1%)
Heartburn/dyspepsia	7/79 (8.9%)
Mucositis/stomatitis (clinical exam) - Oral cavity	17/79 (21.5%)
Mucositis/stomatitis (functional/symp) - Oral cav	10/79 (12.7%)
Nausea	49/79 (62%)
Pain - Abdomen NOS	24/79 (30.4%)
Vomiting	15/79 (19%)
General disorders
Edema: limb	11/79 (13.9%)
Fatigue (asthenia, lethargy, malaise)	64/79 (81%)
Fever in absence of neutropenia, ANC lt1.0x10e9/L	17/79 (21.5%)
Pain-Other	11/79 (13.9%)
Rigors/chills	5/79 (6.3%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)	21/79 (26.6%)
AST, SGOT	22/79 (27.8%)
Alkaline phosphatase	21/79 (26.6%)
Bilirubin (hyperbilirubinemia)	6/79 (7.6%)
Leukocytes (total WBC)	42/79 (53.2%)
Lymphopenia	21/79 (26.6%)
Neutrophils/granulocytes (ANC/AGC)	52/79 (65.8%)
Platelets	26/79 (32.9%)
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)	10/79 (12.7%)
Anorexia	17/79 (21.5%)
Calcium, serum-low (hypocalcemia)	6/79 (7.6%)
Glucose, serum-high (hyperglycemia)	25/79 (31.6%)
Potassium, serum-high (hyperkalemia)	5/79 (6.3%)
Potassium, serum-low (hypokalemia)	8/79 (10.1%)
Sodium, serum-low (hyponatremia)	6/79 (7.6%)
Musculoskeletal and connective tissue disorders
Pain - Back	6/79 (7.6%)
Pain - Extremity-limb	5/79 (6.3%)
Pain - Muscle	9/79 (11.4%)
Nervous system disorders
Dizziness	9/79 (11.4%)
Neuropathy: sensory	24/79 (30.4%)
Pain - Head/headache	12/79 (15.2%)
Taste alteration (dysgeusia)	14/79 (17.7%)
Psychiatric disorders
Insomnia	11/79 (13.9%)
Mood alteration - anxiety	8/79 (10.1%)
Mood alteration - depression	6/79 (7.6%)
Renal and urinary disorders
Urinary frequency/urgency	4/79 (5.1%)
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	4/79 (5.1%)
Cough	11/79 (13.9%)
Dyspnea (shortness of breath)	5/79 (6.3%)
Skin and subcutaneous tissue disorders
Dry skin	9/79 (11.4%)
Hyperpigmentation	7/79 (8.9%)
Pruritus/itching	4/79 (5.1%)
Rash/desquamation	13/79 (16.5%)
Rash: hand-foot skin reaction	27/79 (34.2%)
Vascular disorders
Hypertension	5/79 (6.3%)
Hypotension	5/79 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.