Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
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ClinicalTrials.gov Identifier: NCT01757288 |
Recruitment Status :
Completed
First Posted : December 28, 2012
Results First Posted : October 5, 2021
Last Update Posted : October 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER | Drug: NAB-PACLITAXEL Drug: PACLITAXEL | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is Phase I/II study. Phase I has 1 arm and Phase II has 2 arms (total 3 arms) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A RANDOMIZED PHASE I/II STUDY OF NAB-PACLITAXEL, OR PACLITAXEL, PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY FOLLoWED BY CONSOLIDATION IN PATIENTS WITH FAVORABLE PROGNOSIS INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER (NSCLC) |
Actual Study Start Date : | March 25, 2013 |
Actual Primary Completion Date : | June 3, 2019 |
Actual Study Completion Date : | June 3, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: PACLITAXEL (Phase II, Arm A)
PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY
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Drug: PACLITAXEL |
Experimental: NAB-PACLITAXEL (Phase II, Arm B)
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
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Drug: NAB-PACLITAXEL
nab-Paclitaxel 40 mg/m2 IV/30min/wk x6 wks
Other Name: Abraxan |
Experimental: NAB-PACLITAXEL (Phase I)
NAB-PACLITAXEL PLUS CARBOPLATIN WITH CONCURRENT RADIATION THERAPY nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
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Drug: NAB-PACLITAXEL
nab-Paclitaxel 50 mg/m2 IV/30min/wk x6 wks
Other Name: Abraxan |
- 2-year Overall Survival (Phase II) [ Time Frame: 2 years ]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.
- The Feasibility of Concurrent Carboplatin/Nab-Paclitaxel and Radiation Therapy [ Time Frame: 60 days of the start of treatment ]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.
- Overall Response Rate for the Patients Receiving Carboplatin/ Paclitaxel or Carboplatin/ Nab-paclitaxel With Radiation Therapy [ Time Frame: 1,6,12,18,24 month ]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
- Proportion of Participants With Progression-free Survival (Phase II) [ Time Frame: 2 years ]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.
- Median Overall Survival (Phase II) [ Time Frame: every 6 months up to 24 months (approx. 22 months) ]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.
- EuroQol-5Dimension (EQ-5D) MUS Score at Baseline [ Time Frame: 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."
- EuroQol-5Dimension (EQ-5D) MUS Score at End of Treatment [ Time Frame: End of treatment (6 weeks) ]
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."
- EuroQol-5Dimension (EQ-5D) VAS Score at Baseline [ Time Frame: 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.
- EuroQol-5Dimension (EQ-5D) VAS Score at End of Treatment [ Time Frame: End of Treatment (6 weeks) ]
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.
- EuroQol-5Dimension (EQ-5D) VAS Score at 24 Month Follow up [ Time Frame: 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.
- EuroQol-5Dimension (EQ-5D) MUS Score at 24 Month [ Time Frame: 24 month follow up ]
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."

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically documented NSCLC; Patients must be M0. Patients with T1-T2 with N2 or T3N1-2 are eligible, if inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
- Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. The boost volume must be limited to < 50% of the ipsilateral lung volume.
- Patients with Zubrod performance status 0-1
- Adequate hematologic function
- FEV1 with ≥ 1200 cc or ≥ 50% predicted
Exclusion Criteria:
- Prior systemic chemotherapy (for lung cancer) and/or thoracic/neck radiotherapy for any reason and/or surgical resection of present cancer
- Exudative, bloody, or cytologically malignant effusions
- Prior therapy with any molecular targeted drugs (for lung cancer)
- Active pulmonary infection not responsive to conventional antibiotics
- Clinically significant cardiovascular event (e.g. myocardial infarction, superior vena cava syndrome (SVC), New York Heart Association (NYHA) classification of heart disease >2 (see Appendix B) within 3 months before entry; or presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
- Patients with > grade 1 neuropathy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757288
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
United States, Pennsylvania | |
UPMC Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75239 |
Principal Investigator: | Yuanyuan Zhang, MD | University of Texas Southwestern Medical Center |
Documents provided by Yuanyuan Zhang, University of Texas Southwestern Medical Center:
Responsible Party: | Yuanyuan Zhang, Instructor of Department of Radiation Oncology, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT01757288 |
Other Study ID Numbers: |
STU 062012-053 |
First Posted: | December 28, 2012 Key Record Dates |
Results First Posted: | October 5, 2021 |
Last Update Posted: | October 28, 2021 |
Last Verified: | October 2021 |
STAGE IIIA/B NSCLC / INOPERABLE LUNG CANCER |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Paclitaxel |
Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |