A Pilot Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) in Central Non-Small Cell Lung Cancer

NCT05138900 | Active Not Recruiting DMC

• 1 other identifier: I 1307721
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a single treatment of targeted radiation (called SBRT or Stereotactic Body Radiation Therapy) can be as safe and effective as multiple doses of radiation in patients with central non-small cell lung cancer

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of grade 3-5 adverse events

  Rates of treatment related grade 3-5 adverse events. Assessed using CTCAE v.5

  Up to 5 years

Secondary Outcomes (4)

• Progression-free Survival

  Up to 5 years

• Overall Survival

  UP to 5 years

• Quality of life scores

  Up to 5 years

• Local Control Rate

  Up to 5 years

Study Arms (1)

Stereotactic Body Radiation Therapy (SBRT)

EXPERIMENTAL

A single fraction of targeted SBRT

Radiation: SBRT

Interventions

SBRT RADIATION

SBRT for central non small cell lung cancer

Also known as: Stereotactic Body Radiation Therapy

Stereotactic Body Radiation Therapy (SBRT)

Eligibility Criteria

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

You may qualify if:

• Have an ECOG Performance Status of ≤ 2. Refer to Appendix A.
• Have histologically proven diagnosis of non-small cell lung cancer (NSCLC).
• Stage cT1-3N0M0 with tumor size \< 6 cm.

You may not qualify if:

• Tumors located within 2 cm in all directions of any mediastinal critical structures, including the bronchial tree, esophagus, heart, brachial plexus, major vessels, spinal cord, phrenic nerve, and recurrent laryngeal nerve, as defined by the International Association for the Study of Lung Cancer (IASLC) (27).
• Participant is considered to be either medically or surgically inoperable by physicians, or participant declines surgery.
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry.
• Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• Contraindication to stereotactic body radiation therapy (SBRT) (including the inability to cooperate with any aspect of SBRT such as the inability to lie still and breathe reproducibly)
• Prior radiation to the volume of lung or mediastinum currently involved by tumor
• Plan for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiation, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol, except at disease progression
• Received an investigational agent within 30 days prior to enrollment
• Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or nursing female participants.
• Unwilling or unable to follow protocol requirements.
• Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive SBRT

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, 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

• Anurag Singh, MD

  Roswell Park Comprehensive Cancer Center

  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: November 15, 2021
• First Posted: December 1, 2021
• Study Start: December 16, 2021
• Primary Completion (Estimated): March 9, 2028
• Study Completion (Estimated): March 9, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)