Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients Non-Small Lung Cancer

NCT01622621 | Terminated Phase 2

• 1 other identifier: 11-000805
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized phase II trial is for medically inoperable early stage non-small cell lung cancer (NSCLC) patients. It is designed to compare the number of patients who are disease free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical intervention arms. SBRT is less invasive and felt to be equally effective to surgery for early stage NSCLC. Surgery is currently the standard of care for these patients. The hypothesis of this study is that SBRT is at least as good as surgery for disease free survival at 2 years.

Conditions

Lung Neoplasms

Keywords

Lung; Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients alive at 2 years (Overall Survival [OS])

  All patients who are alive at 2 years.

  2 years after treatment

Secondary Outcomes (1)

• Number of patients with disease free survival (DFS) at 2 years

  2 years after treatment

Study Arms (4)

Randomized Sublobar Resection

ACTIVE COMPARATOR

Randomized by computer to receive a sublobar resection.

Procedure: Sublobar Resection

Randomized SBRT

ACTIVE COMPARATOR

Randomized by computer to receive Stereotactic Body Radiotherapy (SBRT).

Radiation: Stereotactic Body Radiotherapy (SBRT)

Observation Sublobar Resection

ACTIVE COMPARATOR

Patient decides with doctor to undergo a sublobar resection.

Procedure: Sublobar Resection

Observation SBRT

ACTIVE COMPARATOR

Patient decides with doctor to undergo SBRT.

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Sublobar Resection PROCEDURE

Undergo surgery which removes a sublobar resection of the lung

Observation Sublobar Resection; Randomized Sublobar Resection

Stereotactic Body Radiotherapy (SBRT) RADIATION

54 Gy in 3 fractions

Observation SBRT; Randomized SBRT

Eligibility Criteria

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

You may qualify if:

• Patients must have a suspicious lung nodule for clinical stage I NSCLC.
• Pathologic confirmation at the time of surgery is acceptable. Patients randomized to SBRT require core biopsy for diagnosis prior to treatment.
• Patient must have a mass ≤ 5 cm maximum diameter by CT size estimate that is clinical stage I (T1N0, T2N0)
• Patient must have a CT scan of the chest and upper abdomen and PET-scan within 60 days prior to date of registration.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) or Zubrod performance status 0, 1, or 2.
• Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below:
• Major Criteria:
• Forced expiratory volume in one second (FEV1) ≤ 50% predicted
• Carbon monoxide diffusing capacity (DLCO) ≤ 50% predicted
• Minor Criteria:
• Age ≥75
• FEV1 51-60% predicted
• DLCO 51-60% predicted
• Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization
• Poor left ventricular function (defined as an ejection fraction of 40% or less)

You may not qualify if:

• Patient must not have had previous intra-thoracic radiation therapy.
• No prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer, stage 0 Chronic lymphocytic leukemia (CLL), or other cancer disease-free \> 3 yrs.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dennis Wigle, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: May 1, 2012
• Primary Completion: April 25, 2017
• Study Completion: April 25, 2017
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

US (1)