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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane) and carboplatin with concurrent radiation in local-regionally advanced lung cancer. There are no published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane) at 50mg/m2, and then will begin enrolling patients into the phase II component using either Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation or paclitaxel with carboplatin concurrent with daily radiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACLITAXEL (Phase II, Arm A) | Active Comparator | PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY |
|
| NAB-PACLITAXEL (Phase II, Arm B) | Experimental | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks |
|
| NAB-PACLITAXEL (Phase I) | Experimental | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAB-PACLITAXEL | Drug | nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Overall Survival (Phase II) | 2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 2 years. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy | The feasibility as measured by the number of participants who had grade 3 or higher radiation related esophagitis or pulmonary toxicity or chemotherapy related grade 4 hematological or other non-hematological toxicities occurring within 60 days of the start of treatment; compliance us defined as the completion of the treatment regimen with no more than minor variations. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuanyuan Zhang, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States | ||
| UPMC Cancer Center |
6 patients enrolled in phase I and 92 patients enrolled in phase II, 46 patints were randomized to Arm A, and 46 patients to Arm B.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | NAB-PACLITAXEL (Phase I) | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy |
| FG001 | PACLITAXEL (Phase II, Arm A) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2015 |
Not provided
This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms)
Not provided
Not provided
Not provided
Not provided
| PACLITAXEL | Drug |
|
| NAB-PACLITAXEL | Drug | nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks |
|
|
| 60 days of the start of treatment |
| Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy | The objective response rate (ORR) is defined as the percentage of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria | 1,6,12,18,24 month |
| Proportion of Participants With Progression-free Survival (Phase II) | Proportion of participants with progression free survival at 2 years is computed as the percentage of participants between randomization and local or regional progression, distant metastases, death, or last known follow-up. Estimates of progression free survival will be calculated using the Kaplan-Meir method. | 2 years |
| Median Overall Survival (Phase II) | Median overall survival was based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. | every 6 months up to 24 months (approx. 22 months) |
| EuroQol-5Dimension (EQ-5D) MUS Score at Baseline | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." | Baseline |
| EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome. Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." | End of treatment (6 weeks) |
| EuroQol-5Dimension (EQ-5D) VAS Score at Baseline | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. | Baseline |
| EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. | End of Treatment (6 weeks) |
| EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. | 24 month follow up |
| EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." | 24 month follow up |
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75239 | United States |
PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
| FG002 | NAB-PACLITAXEL (Phase II, Arm B) | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy |
| COMPLETED |
|
| NOT COMPLETED |
|
|
75 patients were eligible for analysis on the phase II portion
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NAB-PACLITAXEL (Phase I) | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks NAB-PACLITAXEL: nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks |
| BG001 | PACLITAXEL (Phase II, Arm A) | PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy |
| BG002 | NAB-PACLITAXEL (Phase II, Arm B) | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | months,years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | 2-year Overall Survival (Phase II) | 2-year overall survival, as measured (by Kaplan-Meir method) as the percentage of patients who were randomized and received carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy survived for 2 years. | This outcome was collected for Phase II participants only 2- year overall survival. | Posted | Mean | Full Range | percentage of participants | 2 years |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy | The feasibility as measured by the number of participants who had grade 3 or higher radiation related esophagitis or pulmonary toxicity or chemotherapy related grade 4 hematological or other non-hematological toxicities occurring within 60 days of the start of treatment; compliance us defined as the completion of the treatment regimen with no more than minor variations. | This outcome was collected for Phase I participants only. (6 total). | Posted | Count of Participants | Participants | 60 days of the start of treatment |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy | The objective response rate (ORR) is defined as the percentage of participants achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria | This outcome was measured from Phase II participants only. Percent CR/PR rates by treatment arm. | Posted | Number | 95% Confidence Interval | percentage of participants | 1,6,12,18,24 month |
| |||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Progression-free Survival (Phase II) | Proportion of participants with progression free survival at 2 years is computed as the percentage of participants between randomization and local or regional progression, distant metastases, death, or last known follow-up. Estimates of progression free survival will be calculated using the Kaplan-Meir method. | This outcome was collected from Phase II participants only | Posted | Median | Full Range | percentage of participants | 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Median Overall Survival (Phase II) | Median overall survival was based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. | This outcome was measured from Phase II participants only. | Posted | Median | 95% Confidence Interval | months | every 6 months up to 24 months (approx. 22 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | EuroQol-5Dimension (EQ-5D) MUS Score at Baseline | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." | This outcome was measure from Phase II participants only | Posted | Median | 95% Confidence Interval | score on a scale | Baseline |
| |||||||||||||||||||||||||||||||||
| Secondary | EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome. Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." | This outcome was measure from Phase II participants only | Posted | Median | 95% Confidence Interval | score on a scale | End of treatment (6 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | EuroQol-5Dimension (EQ-5D) VAS Score at Baseline | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. | This outcome was measure from Phase II participants only | Posted | Median | 95% Confidence Interval | score on a scale | Baseline |
| |||||||||||||||||||||||||||||||||
| Secondary | EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. | This outcome was measure from Phase II participants only | Posted | Median | 95% Confidence Interval | score on a scale | End of Treatment (6 weeks) |
| |||||||||||||||||||||||||||||||||
| Secondary | EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up | The second part of the EQ-5D is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point-interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Possible score ranges from 0-100 with higher scores indicating better outcome. | This outcome measure was only collected for one participant a 24 months due to all other participants not completing the QOL timepoint | Posted | Mean | 95% Confidence Interval | score on a scale | 24 month follow up |
| |||||||||||||||||||||||||||||||||
| Secondary | EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month | EQ-5D is a two-part questionnaire. The first part of mean utility score (MUS) consists of five items addressing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on three levels: 1-no problems, 2- slight problems, and 3-moderate problems, 4-severe problems, 5-extreme problems. Possible score ranges from 5-25 with higher scores indicating worse outcome.Both the five-item index score and the VAS score are transformed into a utility score between 0-"worst health state" and 1-"best health state." | This outcome measure was only collected for one participant a 24 months due t oall other participants not completing the QOL timepoint | Posted | Median | 95% Confidence Interval | score on a scale | 24 month follow up |
|
4 years
RECIST criteria
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 | NAB-PACLITAXEL (Phase I) | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6wks XRT 6000 cGy | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | PACLITAXEL (Phase II, Arm A) | PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY Paclitaxel 50 mg/m2 IV/1h/wk* x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy | 2 | 38 | 0 | 38 | 38 | 38 |
| EG002 | NAB-PACLITAXEL (Phase II, Arm B) | NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy | 3 | 37 | 0 | 37 | 37 | 37 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute respiratory failure | Cardiac disorders | Systematic Assessment |
| ||
| alanine aminotransferase increased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| alopecia | Immune system disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| anorexia | Gastrointestinal disorders | Systematic Assessment |
| ||
| arthralgias | General disorders | Systematic Assessment |
| ||
| aspartate aminotransferase increased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| creatnine elevated | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| dercreased lymphocytes | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| decreased neutrophil count | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| decreased platelet count | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| dehydration | General disorders | Systematic Assessment |
| ||
| decreased WBC | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| dermatitis | General disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| dry mouth | General disorders | Systematic Assessment |
| ||
| dysgeusia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| albumin decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Alkaline phosphatase increased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| hyponatremia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| thromboembolic event | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| lymphocyte count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| pleural effusion | General disorders | Systematic Assessment |
| ||
| sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| fatigue | General disorders | Systematic Assessment |
| ||
| platelet count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| GERD | Gastrointestinal disorders | Systematic Assessment |
| ||
| nausea | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| neutrophil count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| dizziness | Nervous system disorders | Systematic Assessment |
| ||
| dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| dysphagia | General disorders | Systematic Assessment |
| ||
| dyspnea | General disorders | Systematic Assessment |
| ||
| edema feet | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| epistaxis | General disorders | Systematic Assessment |
| ||
| esophageal stenosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| esophagitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| fecal incontinence | Gastrointestinal disorders | Systematic Assessment |
| ||
| gait disturbance | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| burning in mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| restless leg syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| anal fungal rash | Gastrointestinal disorders | Systematic Assessment |
| ||
| seasonal allergies | General disorders | Systematic Assessment |
| ||
| stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| post nasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| bilateral upper extremity lymphedema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| abdominal cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
| ||
| throat pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| head congestion | General disorders | Systematic Assessment |
| ||
| chest congestion | General disorders | Systematic Assessment |
| ||
| difficulty swallowing | General disorders | Systematic Assessment |
| ||
| BUN elevated | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| pleuritic pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| radiation fibrosis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| right clavicular swelling | General disorders | Systematic Assessment |
| ||
| Serum amylase increased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| urinary tract infection | Infections and infestations | Systematic Assessment |
|
For Quality of life endpoints, we were limited by the log questionnaire completion rate. The number of patients completed quality of life questionnaire ranged from 1-8 patients in each are at month 3,6,9,12. Additionally, there was a high rate of missing data for FACT series questionnaire. As a result, we are reporting EQ-5D result at baseline and end of treatment.
The responsible party Dr. Hak Choy has been replaced with the Yuanyuan Zhang as Dr. Choy has left UTSouthwestern Medical Center.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yuanyuan Zhang | UT Southwestern Medical Center | 214-648-6764 | Yuanyuan.Zhang@UTSouthwestern.edu |
| May 25, 2021 |
| Prot_SAP_000.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
|
|
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy
|
|
|
|
|
|
|
|
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks Carboplatin AUC **2 IV/30 min/wk x6 wks XRT 6000 cGy |
|
|