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| ID | Type | Description | Link |
|---|---|---|---|
| 2003-07 | Other Identifier | CCRRC | |
| JT 1436 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.
To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.
To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iressa and RT | Experimental | Iressa plus thoracic RT at the following dose levels:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD1839 (Iressa) | Drug |
| ||
| Thoracic Radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Affected by Treatment-related Morbidities | See "Adverse Events" section for specific toxicities | Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Definitions of objective tumor response
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Werner-Wasik, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Kimmel Cancer Center at Thomas Jefferson University | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iressa and RT | Iressa plus thoracic RT at the following dose levels:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, 1, 3, and 5 months post-treatment |
| Progression-free Survival | Baseline to date of progression |
| Survival From Starting Gefitinib | Baseline to date of expiration |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Iressa and RT | Iressa plus thoracic RT at the following dose levels:
ZD1839 (Iressa) Thoracic Radiotherapy |
| 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, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | Patients Affected by Treatment-related Morbidities | See "Adverse Events" section for specific toxicities | Posted | Number | participants | Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy |
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| Secondary | Tumor Response | Definitions of objective tumor response
| Posted | Number | participants | Baseline, 1, 3, and 5 months post-treatment |
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| Secondary | Progression-free Survival | Posted | Median | Full Range | months | Baseline to date of progression |
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| Secondary | Survival From Starting Gefitinib | Posted | Median | Full Range | months | Baseline to date of expiration |
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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 | Iressa and RT | Iressa plus thoracic RT at the following dose levels:
ZD1839 (Iressa) Thoracic Radiotherapy | 5 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shoulder pain | General disorders |
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| Fatigue | General disorders |
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| Dysphagia | General disorders |
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| Cough | General disorders |
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| Nausea | General disorders |
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| Diarrhea | General disorders |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Decreased hemoglobin | Blood and lymphatic system disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
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| Increased alkaline phosphatase | Blood and lymphatic system disorders |
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| Abdominal pain | General disorders |
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| Decreased whole blood count | Blood and lymphatic system disorders |
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| Weight loss | General disorders |
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| Sensory neuropathy | Nervous system disorders |
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| Ulceration | Skin and subcutaneous tissue disorders |
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| Dehydration | General disorders |
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| Headache | General disorders |
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| Dizziness | General disorders |
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| Chest pain | General disorders |
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| Dry skin | Skin and subcutaneous tissue disorders |
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| Side pain | General disorders |
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| Bladder pain | General disorders |
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| Salivary gland changes | General disorders |
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| Alopecia | General disorders |
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| Throat pain | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Werner-Wasik, MD | Thomas Jefferson University | 215-955-6702 | Maria.Werner-Wasik@jeffersonhospital.org |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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