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Feasibility Study of SBRT Plus Chemotherapy for Non-Small Cell Lung Carcinoma

NCT02319889 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-02-01

No results posted yet for this study

Summary

This pilot clinical trial studies stereotactic body radiation therapy followed by combination chemotherapy in treating patients with non-small cell lung cancer. Stereotactic body radiation therapy is a specialized radiation therapy that delivers one to five high doses of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue than conventional radiation. Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving stereotactic body radiation therapy, followed by carboplatin, and paclitaxel albumin-stabilized nanoparticle formulation may kill more tumor cells and result in a better and more durable response than conventional radiation and chemotherapy. The purpose of this study is to test the safety of this approach prior to larger studies.

Conditions

  • Stage I Non-Small Cell Lung Cancer
  • Stage II Non-Small Cell Lung Cancer

Interventions

RADIATION

Stereotactic Body Radiotherapy

Undergo SBRT

DRUG

Carboplatin

Given IV

DRUG

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Mitchell Machtay, MD · University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-02
Primary Completion
2016-07-06
Completion
2017-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02319889 on ClinicalTrials.gov