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NCT01757288 · ClinicalTrials.gov registry record · Phase 1
Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
A Phase 1 study of Stage Iiia/b Nsclc / Inoperable Lung Cancer, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
- 5
- Study locations
NCT01757288: Completed Phase 1 study of Stage Iiia/b Nsclc / Inoperable Lung Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT01757288 is a Phase 1 study of Stage Iiia/b Nsclc / Inoperable Lung Cancer that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 98 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01757288, a Phase 1 study of Stage Iiia/b Nsclc / Inoperable Lung Cancer, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG PACLITAXEL
- DRUG NAB-PACLITAXEL
Study Locations (5)
Tennessee
- Sarah Cannon Research Institute - Nashville
- Vanderbilt-Ingram Cancer Center - Nashville
New York
- University of Rochester - Rochester
Pennsylvania
- UPMC Cancer Center - Pittsburgh
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2013-03-25 |
| Est. Completion | 2019-06-03 |
| Phase | Phase 1 |
What the finished NCT01757288 record still lists
NCT01757288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% higher).
The record links to 1 condition, with Stage Iiia/b Nsclc / Inoperable Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which PACLITAXEL is the first listed.
NCT01757288 lists 5 locations in 4 states (Tennessee, New York, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT01757288 about?
NCT01757288 is a clinical study titled "Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC". 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 th...
What is the current status of trial NCT01757288?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2013-03-25. Estimated completion is 2019-06-03.
What conditions does trial NCT01757288 study?
This clinical trial studies the following conditions: Stage Iiia/b Nsclc / Inoperable Lung Cancer.
What interventions are being tested in trial NCT01757288?
The interventions under investigation include: PACLITAXEL (DRUG), NAB-PACLITAXEL (DRUG).
Who is sponsoring clinical trial NCT01757288?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01757288 being conducted?
This trial has 5 study locations across New York, Pennsylvania, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01757288's enrollment target sits among peer trials
98 592nd of 2000 higher than 1,404 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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