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

NCT02250378 | Withdrawn DMC

• 3 other identifiers: 2N-14-3NCI-2014-01916P30CA014089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

  Treatment related toxicities will be assessed and recorded for each patient receiving treatment.

  Up to 12 months after surgery

• Rates of perioperative complications including blood loss, days in the intensive care unit, and operative time

  Up to 12 months after surgery

• Feasibility, determined by the number of patients who are able to complete wedge resection as well as receive the full dose of stereotactic radiosurgery

  Up to 12 months after surgery

Secondary Outcomes (2)

• Pathologic response rates

  Up to 12 months after surgery

• Quality of life assessment

  Up to 12 months after surgery

Other Outcomes (5)

• Imaging characteristics that may predict response based on DP-CT and PET-CT scans

  Up to 30 days after stereotactic radiosurgery

• Changes in perfusion using DP-CT scans

  Baseline to up to 30 days after stereotactic radiosurgery

• Changes in FDG uptake

  Baseline to up to 12 months after surgery

Study Arms (1)

Treatment (stereotactic radiosurgery, wedge resection)

EXPERIMENTAL

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.

Radiation: stereotactic radiosurgery; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Other: quality-of-life assessment

Interventions

stereotactic radiosurgery RADIATION

Undergo stereotactic radiosurgery

Treatment (stereotactic radiosurgery, wedge resection)

therapeutic conventional surgery PROCEDURE

Undergo wedge resection

Treatment (stereotactic radiosurgery, wedge resection)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (stereotactic radiosurgery, wedge resection)

quality-of-life assessment OTHER

Ancillary studies

Also known as: quality of life assessment

Treatment (stereotactic radiosurgery, wedge resection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Eugene Chung

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

US (1)