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

Phase 2

Terminated

• Conditions: Lung Neoplasms
• Interventions: Procedure: Sublobar Resection; Radiation: Stereotactic Body Radiotherapy (SBRT)

• Registration Number: NCT01622621
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

The current standard of care for Stage I Non-Small Lung Cancer (NSCLC) is sublobar surgical resection. Recent trials have suggested that early stage NSCLC might be successfully treated with SBRT amongst those who are medically inoperable. SBRT is the precise delivery of a high dose of radiation to control tumors while limiting damage to surrounding normal tissues. Patients on the SBRT arm will receive 54 Grays (Gy) in 3 fractions. One gray is the absorption of one joule of energy, in the form of ionizing radiation, per kilogram of matter. Recent advances with three-dimensional conformal and Intensity Modulated Radiotherapy (IMRT) techniques can now compensate for lung motion and allow delivery of high-dose, single fractions to the primary lung tumor for patients with clinical state I NSCLC.

Local control and survival results appear promising. SBRT for early stage lung cancer may offer a potentially equivalent, non-invasive treatment alternative to surgical resection. Additionally, SBRT may be associated with fewer complications and better quality of life. SBRT may be an acceptable or even preferred treatment option in higher-risk patients not able to tolerate a surgical lobectomy. This clinical dilemma is increasingly faced in our lung cancer practice at Mayo Clinic, with no comparative effectiveness data to guide treatment decisions.

Patients will be evaluated by both Thoracic Surgery and Radiation Oncology. Randomization can occur through either group but a patient must see both in consultation prior to randomization. For patients meeting enrollment criteria but unwilling to participate in randomization, observational arms for each of SBRT and sublobar resection will enroll up to 24 patients as part of the 96 patient total.

The patients will receive the following tests as part of their clinical care:

* Computed Tomography (CT)-Positron Emission Tomography (PET) will be used for mediastinal imaging

* Endobronchial/endoscopic ultrasound (EBUS/EUS)-Fine Needle Aspiration (FNA) or mediastinoscopy will be used for pathologic assessment of level 2 lymph nodes (N2) greater than 1 cm in the short axis on CT scan and/or SUV greater than 1.5 fold background

* Follow-up CT scans at 6 months, 12 months, 18 months, and 24 months for the Surgery and SBRT groups.

* Follow-up Pulmonary Function Tests at 1 year

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-15
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-19
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized Sublobar Resection	Sublobar Resection	Randomized by computer to receive a sublobar resection.
Observation SBRT	Stereotactic Body Radiotherapy (SBRT)	Patient decides with doctor to undergo SBRT.
Randomized SBRT	Stereotactic Body Radiotherapy (SBRT)	Randomized by computer to receive Stereotactic Body Radiotherapy (SBRT).
Observation Sublobar Resection	Sublobar Resection	Patient decides with doctor to undergo a sublobar resection.

Primary Outcome Measures

Name	Time	Method
Number of patients alive at 2 years (Overall Survival [OS])	2 years after treatment	All patients who are alive at 2 years.

Secondary Outcome Measures

Name	Time	Method
Number of patients with disease free survival (DFS) at 2 years	2 years after treatment	All patients who are alive and free of disease at 2 years. Disease burden will be determined by computed tomography.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States