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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001845-33 | EudraCT Number |
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The study was terminated because recruitment was too slow.
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This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity. |
|
| Placebo | Placebo Comparator | Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants will receive placebo tablets (matched to erlotinib) once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Disease Progression | Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported. | From inclusion in the study until disease progression (maximum up to 3 years overall) |
| Time to Progression (TTP) | Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months. | From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died | The number of participants who died from any cause was reported. | From inclusion in the study until death from any cause (maximum up to 3 years overall) |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcorcón | 28922 | Spain | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants with histologically confirmed advanced squamous cell carcinoma (SCC) of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 milligrams (mg) once daily for 1 year until disease progression or intolerable toxicity. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Erlotinib |
| Drug |
Erlotinib will be given as 150 mg PO once daily. |
|
|
| Standard of care | Other | Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care. |
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OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.
| From inclusion in the study until death from any cause (maximum up to 3 years overall) |
| Barcelona |
| 08025 |
| Spain |
| Barcelona | 08036 | Spain |
| Barcelona | 08907 | Spain |
| Barcelona | 08916 | Spain |
| Burgos | 09005 | Spain |
| Córdoba | 14004 | Spain |
| Donostia / San Sebastian | 20012 | Spain |
| Donostia / San Sebastian | 20080 | Spain |
| Granada | 18014 | Spain |
| Guadalajara | 19002 | Spain |
| Jaén | 23007 | Spain |
| Lugo | 27004 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28033 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28041 | Spain |
| Murcia | 30008 | Spain |
| Ourense | 32005 | Spain |
| Palma de Mallorca | 07014 | Spain |
| Salamanca | 37007 | Spain |
| Santander | 39008 | Spain |
| Seville | 41009 | Spain |
| Seville | 41013 | Spain |
| Toledo | 45004 | Spain |
| Valencia | 41014 | Spain |
| Valencia | 46015 | Spain |
| Valencia | 46026 | Spain |
| Zamora | 49021 | Spain |
| Zaragoza | 50009 | Spain |
| Placebo |
Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) Population: All participants who were randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity. |
| BG001 | Placebo | Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex/Gender, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Disease Progression | Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported. | ITT Population. | Posted | Number | participants | From inclusion in the study until disease progression (maximum up to 3 years overall) |
|
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| |||||||||||||||||||||||||||||
| Primary | Time to Progression (TTP) | Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months. | ITT Population. | Posted | Median | 95% Confidence Interval | months | From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died | The number of participants who died from any cause was reported. | ITT Population. | Posted | Number | participants | From inclusion in the study until death from any cause (maximum up to 3 years overall) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months. | ITT Population. | Posted | Median | 95% Confidence Interval | months | From inclusion in the study until death from any cause (maximum up to 3 years overall) |
|
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From Baseline until end of treatment (up to 1 year)
ITT Population. Adverse events (AEs) are organized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC), but the AE terms included below are same as they were originally registered and saved.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib | Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity. | 4 | 46 | 36 | 46 | ||
| EG001 | Placebo | Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity. | 2 | 48 | 31 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Dental extraction | Surgical and medical procedures | MedDRA (13.1) | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Aneurism | Vascular disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Resection of right cervical tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Acufenos | Ear and labyrinth disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Earache | Ear and labyrinth disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dyspesia | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Stomatitus | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Edema | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Localized edema | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Mucosa inflammation | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Musculoskeletal rigidity | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Skin toxicity | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
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The Study was terminated early as a result of slow recruitment. Results should be interpreted with consideration of the small sample size.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
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| Unknown |
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