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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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year overall survival from randomization for patients receiving carboplatin/paclitaxel or carboplatin/nab-paclitaxel with radiation therapy

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Hak Choy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

STU 062012-053

NCT ID:

NCT01757288

Start Date:

March 2013

Completion Date:

December 2018

Related Keywords:

  • INOPERABLE STAGE IIIA/B NON-SMALL CELL LUNG CANCER
  • INOPERABLE LUNG CANCER
  • STAGE IIIA/B NON-SMALL CELL LUNG CANCER
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Texas Southwestern Medical CenterDallas, Texas