NCT02319889

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety/feasibility of delivering chemotherapy after definitive stereotactic body radiation therapy (SBRT) for selected stage/situations of non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To determine the 1-year progression free survival in the sub-population of patients with stage IB/II NSCLC, i.e. the "curative intent" subgroup of patients. OUTLINE: Patients undergo stereotactic body radiation therapy every other day for up to 14 days for a total of 5 fractions. After a break period of about 30 days, patients will then start chemotherapy. Patients will receive carboplatin intravenously (IV) over 30-40 minutes on day 1 and paclitaxel albumin-stabilized nanoparticle formulation IV over 30-40 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 1 year.

Conditions

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

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiotherapy	Undergo SBRT
DRUG	Carboplatin	Given IV
DRUG	Paclitaxel Albumin-Stabilized Nanoparticle Formulation	Given IV

Timeline

• Start date: 2016-02-02
• Primary completion: 2016-07-06
• Completion: 2017-01-19
• First posted: 2014-12-18
• Last updated: 2017-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study