Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer

NCT ID: NCT02250378

Last Updated: 2015-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-09-30

Brief Summary

This pilot clinical trial studies the side effects and how well stereotactic radiosurgery followed by wedge resection works in treating patients with early stage non-small cell lung cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive type of surgery for removal of the tumor and a small amount of normal tissue around it. Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option for patients who cannot receive standard treatment with lobectomy.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the safety and feasibility of a wedge resection following stereotactic body radiation therapy (SBRT) for early stage peripheral non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To assess pathologic response rates to SBRT as determined by pathologic examination of resected tumors.

II. To prospectively assess patient quality of life when treated with SBRT and wedge resection.

TERTIARY OBJECTIVES:

I. To describe the location of viable tumor and to correlate pathologic response rates with radiation dose, size of tumor, and tumor histology.

II. To correlate pathologic response rates and functional imaging with pre- and post-treatment dual-input perfusion (DP)-computed tomography (CT) and positron emission tomography (PET)-CT.

III. To correlate changes in serum levels of deoxyribonucleic acid (DNA) methylation and circulating tumor cells (CTC) with pathologic response rates.

OUTLINE:

Patients undergo stereotactic radiosurgery every other day for 3 or 5 fractions (depending on the size tumor and proximity to the chest wall). Within 4-6 weeks after completion of stereotactic radiosurgery, patients undergo wedge resection.

After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IA Non-small Cell Lung Cancer; Stage IB Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (stereotactic radiosurgery, wedge resection)

Patients undergo stereotactic radiosurgery every other day for 3 or 5 fractions (depending on the size tumor and proximity to the chest wall). Within 4-6 weeks after completion of stereotactic radiosurgery, patients undergo wedge resection.

Group Type: EXPERIMENTAL

stereotactic radiosurgery

Intervention Type: RADIATION

Undergo stereotactic radiosurgery

therapeutic conventional surgery

Intervention Type: PROCEDURE

Undergo wedge resection

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

Interventions

stereotactic radiosurgery

Undergo stereotactic radiosurgery

Intervention Type: RADIATION

therapeutic conventional surgery

Undergo wedge resection

Intervention Type: PROCEDURE

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

quality of life assessment

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• Biopsy proven non-small cell lung cancer
• Maximum tumor dimension =< 5 cm
• No clinical evidence of N1, N2 or N3 lymph nodes as assessed by CT and/or PET-CT
• No evidence of distant metastatic disease
• Tumor verified by a thoracic surgeon to be in a location that will permit a sublobar resection
• Tumor located peripherally within the lung (peripheral defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions) and not touching the mediastinal pleura
• Pulmonary function tests (PFTs) with diffusing capacity of the lung for carbon monoxide (DLCO) within 90 days prior to registration
• Patient at high-risk of complications from lobectomy meeting a minimum of one major criteria or two minor criteria as described below:

• Major criteria

• Predicted postoperative forced expiratory volume in one second (FEV1) =< 40%
• Predicted postoperative DLCO =< 40%
• Age >= 72
• Minor criteria

• Predicted postoperative FEV1 41-60%
• Predicted postoperative DLCO 41-60%
• Pulmonary hypertension (defined by a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization
• Poor left ventricular function (defined as an ejection fraction 40% or less)
• Resting or exercising arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%
• Partial pressure of carbon monoxide (pCO2) > 45 mm Hg
• Modified Medical Research Council Dyspnea Scale >= 3
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Pregnant women
• Patients with central tumors within the proximal tree or touching the mediastinal pleura
• Patients with evidence of distant metastatic disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene Chung

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2014-01916

Identifier Type: REGISTRY

Identifier Source: secondary_id

2N-14-3

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2N-14-3

Identifier Type: -

Identifier Source: org_study_id