Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00153803
• Collaborator: Sanofi (Industry), Genentech, Inc. (Industry)
• Enrollment: 245
• Locations: 65
• Arms: 2
• Duration (Months): 107
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung; Non-small Cell Lung Cancer; NSCLC	Drug: Erlotinib (tarceva); Drug: Placebo	Phase 3

Detailed Description

The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to incorporate into combined modality therapy in the early stages of lung cancer. Based on these data, erlotinib is an attractive novel approach to maintenance therapy in unresectable stage III NSCLC following completion of concomitant chemoradiation. Although, a subset of patients with unresectable stage III NSCLC will be long-term survivors following chemotherapy and thoracic radiation therapy, the vast majority relapse within the first year following therapy and eventually die from chemotherapy refractory disease. We hypothesize that the introduction of an potent tyrosine kinase inhibitor to the epidermal growth factor receptor following effective concomitant chemoradiotherapy with docetaxel and carboplatin will prolong the progression-free survival time for these patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 245 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following Concurrent Docetaxel, Carboplatin, and Thoracic Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (D0410).
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Erlotinib (Tarceva) 150mg: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	Drug: Erlotinib (tarceva); Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
Placebo Comparator: 2 Matched Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.	Drug: Placebo; Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [5 years]

   Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.

Secondary Outcome Measures

1. Overall Survival [From date of randomization until the date of death from any cause, assessed up to 50 months]

2. Percent of Participants Surviving 3 Years [36 months]

3. Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation [18 months]

   Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.

4. Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo [18 months]

   Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)

• No evidence of metastatic disease

• No prior treatment

• Adequate organ function

• Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)

Exclusion Criteria:

• Metastasis

• Prior treatment

• Malignant pleural or pericardial effusion

• Peripheral neuropathy >= grade 2

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama	United States	35235
2	Oncology Specialties, P.C.	Huntsville	Alabama	United States	35801
3	Cooper Clinic	Fort Smith	Arkansas	United States	72913
4	Genesis Cancer Center	Hot Springs	Arkansas	United States	71913
5	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94704
6	Northstate Cancer Speciality	Redding	California	United States	96001
7	Mercy General Hospital	Sacramento	California	United States	95816
8	St. Francis Hospital Cancer Center	Hartford	Connecticut	United States	06105
9	Connecticut Oncology Group	Middletown	Connecticut	United States	06457
10	George Bray Cancer Center/New Britain General Hospital	New Britain	Connecticut	United States	06050
11	Oncology and Hematology Associates, PC	New London	Connecticut	United States	06320
12	Whittingham Cancer Center at Norwalk Hospital	Norwalk	Connecticut	United States	06856
13	Hematology/Oncology PC/Carl and Dorothy Bennet Cancer Center	Stamford	Connecticut	United States	06902
14	Washington Cancer Institute	Washington	District of Columbia	United States	20010
15	Pasco Hernando Oncology Associates	Brooksville	Florida	United States	34613
16	Florida Cancer Specialists	Fort Myers	Florida	United States	33901
17	Lee Cancer Clinic	Fort Myers	Florida	United States	33919
18	Jupiter Medical Center	Jupiter	Florida	United States	33458
19	Cancer Care of North Florida	Lake City	Florida	United States	32055
20	Pasco/Hernando Oncology	New Port Richey	Florida	United States	34652
21	Mid Florida Oncology	Orange City	Florida	United States	32763
22	MD Anderson	Orlando	Florida	United States	32806
23	Oncology & Hematology Association of West Broward	Tamarac	Florida	United States	33321
24	Palm Beach Cancer Institute	West Palm Beach	Florida	United States	33410
25	Alexian Brothers Hospital Network	Elk Grove Village	Illinois	United States	60007
26	Joliet Hematology Associates	Joliet	Illinois	United States	60435
27	Investigative Clinical Research of Indiana LLC	Indianapolis	Indiana	United States	46254
28	Howard Regional Health System	Kokomo	Indiana	United States	46904
29	McFarland Clinic	Ames	Iowa	United States	50010
30	Kentucky Cancer Clinic	Hazard	Kentucky	United States	41701
31	Western Hematology Oncology	Paducah	Kentucky	United States	42003
32	Maine Center for Cancer Medicine	Scarborough	Maine	United States	04074
33	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215
34	Union Memorial Hospital	Baltimore	Maryland	United States	21218
35	Harbor View Cancer Center	Baltimore	Maryland	United States	21225
36	Franklin Square Hospital Center	Baltimore	Maryland	United States	21237
37	Frederick Smith, MD	Chevy Chase	Maryland	United States	20815
38	Community Hematology Oncology	Olney	Maryland	United States	20832
39	Lahey Clinic Medical Center	Burlington	Massachusetts	United States	01805
40	Fallon Clinic Hematology/ Oncology	Worcester	Massachusetts	United States	01608
41	Bay Medical Cancer Center	Bay City	Michigan	United States	48706
42	Southeast Nebraska Hematology/Oncology	Lincoln	Nebraska	United States	68510
43	Methodist Cancer Center	Omaha	Nebraska	United States	68114
44	Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
45	Dartmouth-Hitchcock-Keene	Keene	New Hampshire	United States	03431
46	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756
47	The Center for Cancer and Hematologic Disease	Cherry Hill	New Jersey	United States	00000
48	Sussex County Medical Associates	Newton	New Jersey	United States	07860
49	Lincoln Hospital	Bronx	New York	United States	10451
50	Queens Medical Associates	Fresh Meadows	New York	United States	11365
51	Winthrop University Hospital	Mineola	New York	United States	11501
52	Hematology Oncology Associates of Rockland, PC	New York	New York	United States	10956
53	Southeastern Medical Oncology Center	Goldsboro	North Carolina	United States	27534
54	Aultman Cancer Center	Canton	Ohio	United States	44710
55	The Cleveland Clinic Foundation Hematology/Med Oncology	Cleveland	Ohio	United States	44195
56	Legacy Good Samaritan	Portland	Oregon	United States	97201
57	SCOA-SC Onc Assoc	Columbia	South Carolina	United States	29201
58	VA Department of Hematology/Oncology	Houston	Texas	United States	77030
59	Hope Oncology	Richardson	Texas	United States	75080
60	Blood and Cancer Center of East Texas	Tyler	Texas	United States	75701
61	Tyler Hematology/Oncology	Tyler	Texas	United States	75701
62	Veterans Administration Medical Center	White River Junction	Vermont	United States	05009
63	Virginia Oncology Associates Research Program	Newport News	Virginia	United States	23606
64	Olympic Hematology/Oncology	Bremerton	Washington	United States	98310
65	Morgantown Internal Medicine Group	Morgantown	West Virginia	United States	26505

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center
• Sanofi
• Genentech, Inc.

Investigators

• Study Chair: James R Rigas, MD, Norris Cotton Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT00153803
• Other Study ID Numbers: D-0410
• First Posted: Sep 12, 2005
• Last Update Posted: Sep 6, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Dartmouth-Hitchcock Medical Center: Erlotinib; Tarceva; Web based; Stage III NSCLC
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Erlotinib Hydrochloride

Study Results

Participant Flow

Recruitment Details	Period 1: 245 patients were registered & randomized. Of those, 10 patients were ineligible due to incorrect stage, withdrawal of consent, inability to meet radiation therapy parameters, and inadequate functional status. The number of participants for each specific reason for ineligibility is unknown. They did not receive any study intervention.
Pre-assignment Detail	Period 2:Study drug dispensed to only chemoradiation patients who did not experience disease progression, consent withdrawal, death, investigators discretion, or toxicity.

Arm/Group Title	Tarceva	Placebo
Arm/Group Description	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Period Title: Concurrent Chemoradiation
STARTED	123	122
Received Chemoradiation	118	117
COMPLETED	118	117
NOT COMPLETED	5	5
Period Title: Concurrent Chemoradiation
STARTED	118	117
Investigational Drug Dispensed	77	75
COMPLETED	77	75
NOT COMPLETED	41	42

Baseline Characteristics

Arm/Group Title	Tarceva	Placebo	Total
Arm/Group Description	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.	Total of all reporting groups
Overall Participants	123	122	245
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	68	67	67.5
Sex: Female, Male (Count of Participants)
Female	45 36.6%	55 45.1%	100 40.8%
Male	78 63.4%	67 54.9%	145 59.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.8%	2 1.6%	3 1.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 4.9%	7 5.7%	13 5.3%
White	109 88.6%	106 86.9%	215 87.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	7 5.7%	7 5.7%	14 5.7%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival
Description	Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to be considered locoregional disease progression. Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression was considered distant disease progression.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

NA = not available; The data cannot be located/provided due to the PI leaving the institution.

Arm/Group Title	Tarceva	Placebo
Arm/Group Description	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Measure Participants	118	117
Median (Full Range) [Months]	7.4	8.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tarceva, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.165
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.65 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Overall Survival
Time Frame	From date of randomization until the date of death from any cause, assessed up to 50 months

Outcome Measure Data

Analysis Population Description

NA = not available; The data cannot be located/provided due to the PI leaving the institution.

Arm/Group Title	Tarceva	Placebo
Arm/Group Description	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 2 years of therapy.	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Measure Participants	118	117
Median (Full Range) [Months]	16.5	20.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tarceva, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percent of Participants Surviving 3 Years
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tarceva	Placebo
Arm/Group Description	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Measure Participants	118	117
Number [percentage of participants]	37 30.1%	41 33.6%

4. Secondary Outcome

Title	Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Concurrent Chemoradiation
Description	Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tarceva	Placebo
Arm/Group Description	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Measure Participants	118	117
Death	7 5.7%	6 4.9%
Disability	0 0%	0 0%
Life-threatening	2 1.6%	4 3.3%
Hospitalization	26 21.1%	36 29.5%
Impairment/damange	3 2.4%	3 2.5%
Other	1 0.8%	0 0%

5. Secondary Outcome

Title	Serious Adverse Event Profile Relating to Death, Disability, Life-threatening, Hospitalization, and Impairment/Damage for Erlotinib and Placebo
Description	Number of participants with treatment-related serious adverse events (SAEs) observed in each SAE category for each arm relating to death, disability, life-threatening, hospitalization, and impairment/damage is reported. For participants with multiple SAEs, the SAE report having the strongest relationship to study drug is summarized.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tarceva	Placebo
Arm/Group Description	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.	Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Measure Participants	77	75
Death	10 8.1%	6 4.9%
Disability	0 0%	0 0%
Life-threatening	1 0.8%	1 0.8%
Hospitalization (initial or prolonged)	30 24.4%	23 18.9%
Impairment/damange	2 1.6%	1 0.8%
Other	1 0.8%	0 0%

Adverse Events

Time Frame	The intent-to-treat population included 235 eligible randomized patients to the erlotinib arm (n = 118) or placebo arm (n = 117); 245 randomized, 10 became ineligible prior to any treatment. Patients were evaluated with a medical history, physical exam, laboratory studies, and toxicity assessment starting at 1st dose, every 4 weeks for 2 months, then every 8-12 weeks until treatment discontinuation. Participants were evaluated, on average, for 6 months, and through study completion up to 3 years
Adverse Event Reporting Description	Common Toxicities are reported. Adverse events (Serious, Other Adverse Events) are reporting for only those participants who are included in the intent-to-treat population .This study used the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0 for grading and reporting of toxicities and adverse events.
Arm/Group Title	Chemoradiation Before Tarceva		Chemoradiation Before Placebo		Tarceva		Placebo
Arm/Group Description	Tarceva 150mg Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.		Matched Placebo Placebo: Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
All Cause Mortality
	Chemoradiation Before Tarceva		Chemoradiation Before Placebo		Tarceva		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/118 (22%)		27/117 (23.1%)		43/77 (55.8%)		40/75 (53.3%)
Serious Adverse Events
	Chemoradiation Before Tarceva		Chemoradiation Before Placebo		Tarceva		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	36/118 (30.5%)		38/117 (32.5%)		39/77 (50.6%)		23/75 (30.7%)
Blood and lymphatic system disorders
Hemoglobin	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Cardiac disorders
Atrial fibrillation	2/118 (1.7%)	2	1/117 (0.9%)	1	0/77 (0%)	0	1/75 (1.3%)	1
Cardiac Arrhythmia	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Cardiac General	0/118 (0%)	0	1/117 (0.9%)	1	2/77 (2.6%)	2	2/75 (2.7%)	2
Cardiac ischemia/infarction	0/118 (0%)	0	1/117 (0.9%)	1	1/77 (1.3%)	1	0/75 (0%)	0
Hypotension	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Paroxysmal Atrial Tachycardia	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Ventricular fibrillation	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Gastrointestinal disorders
Colitis	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Dehydration	2/118 (1.7%)	2	2/117 (1.7%)	2	0/77 (0%)	0	1/75 (1.3%)	1
Dysphagia (difficulty swallowing)	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Esophagitis	4/118 (3.4%)	4	2/117 (1.7%)	2	0/77 (0%)	0	0/75 (0%)	0
Fistula, Esophagus	0/118 (0%)	0	0/117 (0%)	0	0/77 (0%)	0	1/75 (1.3%)	1
Gastritis	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Gastrointestinal - Other	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Mucositis/stomatitis	0/118 (0%)	0	2/117 (1.7%)	2	0/77 (0%)	0	0/75 (0%)	0
Perforation, GIColon	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Vomiting	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
General disorders
Constitutional Symptoms - Fatigue	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Constitutional Symptoms - Fever	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Constitutional Symptoms- Other	2/118 (1.7%)	2	0/117 (0%)	0	0/77 (0%)	0	1/75 (1.3%)	1
Hemorrhage - Respiratory tract NOS	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Hemorrhage, GI Lower	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Hemorrhage, pulmonary/upper respiratory- Lung	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	1/75 (1.3%)	1
Hemorrhage/Bleeding - Other	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Pain - Abdomen NOS	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Pain - Bone	0/118 (0%)	0	0/117 (0%)	0	2/77 (2.6%)	2	0/75 (0%)	0
Pain - Joint	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Pain - Other	0/118 (0%)	0	0/117 (0%)	0	2/77 (2.6%)	2	0/75 (0%)	0
Pain- Chest/thorax	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Immune system disorders
Allergic Reaction	1/118 (0.8%)	1	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Infections and infestations
Colitis, Infectious	0/118 (0%)	0	0/117 (0%)	0	0/77 (0%)	0	1/75 (1.3%)	1
Febrile neutropenia	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Infection - Blood	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Infection - Foreign body	1/118 (0.8%)	1	0/117 (0%)	0	2/77 (2.6%)	2	0/75 (0%)	0
Infection - Lung	1/118 (0.8%)	1	0/117 (0%)	0	4/77 (5.2%)	4	1/75 (1.3%)	1
Infection - Other	2/118 (1.7%)	2	1/117 (0.9%)	1	5/77 (6.5%)	5	0/75 (0%)	0
Infection - Wound	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Metabolism and nutrition disorders
Hyperglycemia	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Musculoskeletal and connective tissue disorders
Fracture	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	1/75 (1.3%)	1
Musculoskeletal / Soft Tissue - Other	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	1/75 (1.3%)	1
Nervous system disorders
Cerebrovascular Ischemia	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	2/75 (2.7%)	2
Confusion	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Dizziness	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Neurology - Other	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	1/75 (1.3%)	1
Somnolence/depressed level of consciousness	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Renal and urinary disorders
Obstruction - Ureter	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	0/118 (0%)	0	2/117 (1.7%)	2	2/77 (2.6%)	2	3/75 (4%)	3
Hypoxia	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Pleural effusion (non-malignant)	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	1/75 (1.3%)	1
Pneumonitis/pulmonary infiltrates	1/118 (0.8%)	1	2/117 (1.7%)	2	4/77 (5.2%)	4	0/75 (0%)	0
Upper Respiratory - Other	3/118 (2.5%)	3	3/117 (2.6%)	3	3/77 (3.9%)	3	4/75 (5.3%)	4
Skin and subcutaneous tissue disorders
Skin - Other	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Wound complication, non-infectious	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Surgical and medical procedures
Intra-operative Injury - Other	0/118 (0%)	0	0/117 (0%)	0	0/77 (0%)	0	1/75 (1.3%)	1
Vascular disorders
Thrombosis/embolism (vascular access-related)	1/118 (0.8%)	1	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Thrombosis/thrombus/embolism	3/118 (2.5%)	3	4/117 (3.4%)	4	2/77 (2.6%)	2	0/75 (0%)	0
Vascular - Other	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Other (Not Including Serious) Adverse Events
	Chemoradiation Before Tarceva		Chemoradiation Before Placebo		Tarceva		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/118 (10.2%)		8/117 (6.8%)		8/77 (10.4%)		0/75 (0%)
Blood and lymphatic system disorders
Hemoglobin	1/118 (0.8%)	1	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Cardiac disorders
Atrial fibrillation	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Cardiac General - Other	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Gastrointestinal disorders
Constipation	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Dehydration	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Esophagitis	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Gastrointestinal - Other	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Nausea	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
General disorders
Constitutional symptoms - Fever	1/118 (0.8%)	1	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Pain - Chest/Thorax	2/118 (1.7%)	2	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Pain - Other	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Pain - Abdomen NOS	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Hepatobiliary disorders
Pancreatitis	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Immune system disorders
Allergic reaction	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Infections and infestations
Infection - Other	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Musculoskeletal and connective tissue disorders
Fracture	0/118 (0%)	0	1/117 (0.9%)	1	1/77 (1.3%)	1	0/75 (0%)	0
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Pneumothorax	1/118 (0.8%)	1	0/117 (0%)	0	0/77 (0%)	0	0/75 (0%)	0
Cough	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Upper respiratory - other	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Skin and subcutaneous tissue disorders
Skin - Other	0/118 (0%)	0	1/117 (0.9%)	1	0/77 (0%)	0	0/75 (0%)	0
Desquamation	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0
Vascular disorders
Embolism	0/118 (0%)	0	0/117 (0%)	0	1/77 (1.3%)	1	0/75 (0%)	0

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.