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| ID | Type | Description | Link |
|---|---|---|---|
| 78999 | Other Identifier | Stanford University Alternate IRB Approval Number | |
| GIA #12169 | Other Identifier | Aventis | |
| 11804 | Other Identifier | Stanford IRB |
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low accrual
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| Name | Class |
|---|---|
| Aventis Pharmaceuticals | INDUSTRY |
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The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy+Radiation+Surgery | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 20 mg/m2, 75 mg/m2 infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy. | Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival | The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen | This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding. | Specimen collected at time of surgery |
Inclusion Criteria:
Histologically confirmed stage IIIA or IIIB NSCLC
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather A. Wakelee | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21774104 | Result | Kozak MM, Murphy JD, Schipper ML, Donington JS, Zhou L, Whyte RI, Shrager JB, Hoang CD, Bazan J, Maxim PG, Graves EE, Diehn M, Hara WY, Quon A, Le QT, Wakelee HA, Loo BW Jr. Tumor volume as a potential imaging-based risk-stratification factor in trimodality therapy for locally advanced non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):920-6. doi: 10.1097/jto.0b013e31821517db. | |
| 21752720 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel / Carboplatin / XRT + Surgical Resection | Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival | The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported. | All enrolled patients were analyzed in the published manuscript | Posted | Mean | Standard Deviation | standardized uptake value (SUV)max | baseline, 5 weeks after combined chemo-radiation |
|
Patients were followed for toxicity through completion of all protocol defined therapy (approximately 5 months) and for an additional month after completed of all therapy for toxicity (a total of 6-7 months).
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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 | Docetaxel / Carboplatin / XRT + Surgical Resection | Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| esophagitis | Gastrointestinal disorders | Non-systematic Assessment | 1 Grade III during indcution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders |
Accrual was very slow. The study was halted with accrual of only 13 patients. These results were published.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heather Wakelee | Stanford University | 650-736-7221 | hwakelee@stanford.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Carboplatin | Drug | AUC of 2 and 6 infusion |
|
|
| Radiation therapy | Procedure | NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period. |
|
|
| Surgical resection | Procedure | All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe. |
|
|
| baseline, 5 weeks after combined chemo-radiation |
| Result |
| Das M, Donington JS, Murphy J, Kozak M, Eclov N, Whyte RI, Hoang CD, Zhou L, Le QT, Loo BW, Wakelee H. Results from a single institution phase II trial of concurrent docetaxel/carboplatin/radiotherapy followed by surgical resection and consolidation docetaxel/carboplatin in stage III non-small-cell lung cancer. Clin Lung Cancer. 2011 Sep;12(5):280-5. doi: 10.1016/j.cllc.2011.06.003. Epub 2011 Jul 14. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint.
Results were published PMID 21774104
|
|
| Other Pre-specified | Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen | This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding. | Plan was to analyze all patients with adequate tissue for this analysis, but was not done. We did not have sufficient funds for this analysis. | Posted | Specimen collected at time of surgery |
|
|
| Primary | 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy. | Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse. | All patients alive and not censored at 2 years | Posted | Number | participants | Two years |
|
|
|
|
| 8 |
| 13 |
| 10 |
| 13 |
|
| respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| anemia | Blood and lymphatic system disorders |
|
| neutropenia | Blood and lymphatic system disorders |
|
| allergic reaction | Injury, poisoning and procedural complications |
|
| fatigue | General disorders |
|
| dehydration | Metabolism and nutrition disorders |
|
| bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | Resolved with conservative management (no surgical intervention required). |
|
| fatigue | General disorders |
|
| esophagitis | Gastrointestinal disorders |
|
| pneumonitis | Respiratory, thoracic and mediastinal disorders |
|
| neutropenia | Blood and lymphatic system disorders |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |