Not provided
Not provided
Not provided
Not provided
Unable to enroll adequate number of participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung cancer in two fashions:
Subjects will receive standard of care treatment for SCLC with added treatment of Cisplatin injection via endobronchial ultrasound aided bronchoscopy a total of four times. Outcome measurements of tumor growth and survival will be compared to subjects receiving standard of care treatment only.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with limited stage SCLC | Experimental | Subjects with limited stage SCLC treated sequentially with cisplatin. |
|
| Historical Controls | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | 40 mg in 40 mL of normal saline for each of 4 bronchoscopies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solid Tumor Growth After Completion of Interventional Bronchoscopies | The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | 18 months | |
| Overall Survival | Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates. | 5 years |
Not provided
Inclusion Criteria: Competent adult English speaking subjects
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael A. Jantz, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Limited Stage SCLC | Subjects with limited stage SCLC treated sequentially with cisplatin. Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Limited Stage SCLC | Subjects with limited stage SCLC treated sequentially with cisplatin. Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Solid Tumor Growth After Completion of Interventional Bronchoscopies | The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy. | No participants were analyzed because total enrollment numbers were too low to meet any statistical analysis. | Posted | 18 months |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Limited Stage SCLC | Subjects with limited stage SCLC treated sequentially with cisplatin. Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael A. Jantz, MD | University of Florida | 352-273-8737 | michael.jantz@medicine.ufl.edu |
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Progression-free Survival | Posted | 18 months |
|
|
| Secondary | Overall Survival | Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates. | Posted | 5 years |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |