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| ID | Type | Description | Link |
|---|---|---|---|
| IIT 12230 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.
Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel-Carboplatin | Drug | Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Febrile Neutropenia | The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Jablons, MD | Maestro Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States | ||
| Beijing Chaoyang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24255769 | Derived | Zhi X, Gao W, Han B, Yang Y, Li H, Liu D, Wang C, Min G, Long H, Rigas JR, Carey M, Jahan T, Sammann A, Reza J, Wang D, Mann MJ, Jablons DM, He J; China Clinical Trials Consortium. VATS lobectomy facilitates the delivery of adjuvant docetaxel-carboplatin chemotherapy in patients with non-small cell lung cancer. J Thorac Dis. 2013 Oct;5(5):578-84. doi: 10.3978/j.issn.2072-1439.2012.02.05. |
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Enrollment of patients took place at a single center in the United States (Dartmouth-Hitchcock Norris Cotton Cancer Center) and at ten sites in China that were early members of the China Clinical Trials Consortium.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses |
| 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 | Febrile Neutropenia | The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of <10%. | Intent to treat | Posted | Number | participants | 2 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 | Treatment | Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | 10020755 | Systematic Assessment | 4 allergic reactions to docetaxel that required discontinuation of therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Infections and infestations | Febrile neutropenia | Systematic Assessment | Resolved without serious complication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Mann, MD | Maestro | 650-380-9579 | michael.mann@ucsfmedctr.org |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Beijing |
| China |
| Beijing Tumor Hospital | Beijing | China |
| Beijing Youyi Hospital | Beijing | China |
| China-Japan Friendship Hospital | Beijing | China |
| Xuanwu Hospital | Beijing | China |
| First Affiliated Hospital, Guangzhou Medical College | Guangzhou | China |
| Sun Yat-sen Cancer Center | Guangzhou | China |
| Shanghai Chest Hopsital, Pulmonary Medicine | Shanghai | China |
| Shanghai Lung Cancer Center, Shanghai Chest Hospital | Shanghai | China |
| Shanghai Pulmonary Hospital | Shanghai | China |
| Tianjin Cancer Center | Tianjin | China |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 14 |
| 133 |
| 66 |
| 133 |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | Febrile neutropenia | Systematic Assessment |
|
| Infection | Blood and lymphatic system disorders | Febrile neutropenia | Systematic Assessment |
|
| Severe Neutropenia | Blood and lymphatic system disorders | Neutrophil count | Systematic Assessment | requiring hospitalization |
|
| Severe Nausea and Vomiting | Gastrointestinal disorders | Vomiting NOS | Systematic Assessment | Requiring Hospitalization |
|
| Pelvic Infection | Infections and infestations | Pelvis NOS | Systematic Assessment | Requiring Hospitalization |
|
|
| Neutropenia | Blood and lymphatic system disorders | Neutrophil count | Systematic Assessment | Grade 3 and Grade 4 Neutropenia, non-febrile |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |