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Stage I Non-Small Cell Lung Cancer AJCC v7Early Phase 1NCT03348748

Stereotactic Body Radiation Therapy Followed by Surgery in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer

A Early Phase 1 study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Stage I Non-Small Cell Lung Cancer AJCC v7 and Stage IA Non-Small Cell Lung Carcinoma AJCC v7, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
18 Dec 2017to 10 Nov 2025
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Have histologically proven diagnosis of: non-small cell lung cancer (NSCLC) (stage I, II, or IIIa)
  • Neoadjuvant or induction chemotherapy or biological (immune, vaccine, etc.)therapy for stage IIIa is allowed
  • Chemotherapy for another invasive malignancy is permitted if it has been treated definitively and the patient has remained disease free for >3 years
  • Participant is able to undergo surgery (planned lobectomy or wedge resection)
  • Specifically, the participant has been or will have been cleared for surgery at the time of enrollment; the surgeon can accept the baseline tests done within 45 days prior to SBRT to clear the patient for surgery
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) during treatment
  • Participant or legal representative 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

Who cannot join

  • Contraindication to SBRT (this includes the inability to cooperate with any aspect of SBRT: such as the inability to lie still and breathe reproducibly)
  • Previous radiotherapy to the volume of lung or mediastinum currently involved by tumor
  • Previous surgery for this lung or mediastinum tumor
  • Plans for the patient to receive other concomitant antineoplastic therapy (including standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine therapy, and surgery) while on this protocol(does not apply to neoadjuvant therapy as in inclusion criteria) except at disease progression
  • Patients with active systemic, pulmonary, or pericardial infection
  • Pregnant or nursing female participants
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  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator?s opinion deems the participant ineligible
  • Received an investigational agent within 30 days prior to enrollment
  • Stage IIIb

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Three Pilot Studies of Stereotactic Body Radiation Therapy (SBRT) and Surgery in Non-small Cell Lung Cancer

This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety and feasibility of combining single fraction stereotactic body radiation therapy (SBRT) followed by surgery, in thoracic malignancies.

SECONDARY OBJECTIVES:

  1. To estimate overall survival (OS) and progression-free survival (PFS) after single fraction SBRT followed by surgery, in thoracic malignancies.

II. To define any differences in quality of life/toxicity following SBRT based on tumor location/stage/tumor type.

TERTIARY OBJECTIVES:

  1. To assess changes in T cell mediated immunity following SBRT in thoracic malignancies.

OUTLINE: Patients are assigned to 1 of 3 studies.

STUDY 1: Patients with stage I or II non-small cell lung cancer (NSCLC) in the peripheral lung undergo highest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

STUDY 2: Patients with stage I or II NSCLC in the central lung undergo lowest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

STUDY 3: Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.

After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years.

Being tested
Laboratory Biomarker Analysis, Quality-of-Life Assessment, Stereotactic Body Radiation Therapy, Thoracic Surgical Procedure
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Stereotactic Body Radiation TherapyDrug

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo lowest-dose of SBRT

  • Stereotactic Body Radiation TherapyDrug

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo lowest- or higher-dose of SBRT

  • Stereotactic Body Radiation TherapyDrug

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo highest-dose of SBRT

  • Thoracic Surgical ProcedureProcedure or surgery

    Also called Chest Surgery, Thoracic Surgery, Thoracic Surgical Procedures

    Undergo thoracic surgery

Study groups in NCT03348748
Study groupRoleWhat they receive
Study 1 (highest-dose of SBRT, surgery)ExperimentalPatients with stage I or II NSCLC in the peripheral lung undergo highest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Stereotactic Body Radiation Therapy; Procedure: Thoracic Surgical Procedure
Study 2 (lowest-dose of SBRT, surgery)ExperimentalPatients with stage I or II NSCLC in the central lung undergo lowest-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Stereotactic Body Radiation Therapy; Procedure: Thoracic Surgical Procedure
Study 3 (lowest- or higher-dose of SBRT, surgery)ExperimentalPatients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of Stereotactic Body Radiation Therapy over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28.
Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Stereotactic Body Radiation Therapy; Procedure: Thoracic Surgical Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0

    Comparison will be made with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.

    Measured: Up to 10 weeks post-surgery

Secondary outcomes (2)

  1. Overall survival

    Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.

    Measured: Up to 5 years

  2. Progression free survival

    Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2017
  2. Study start18 Dec 2017
  3. Primary completion12 Jul 2021
  4. Study completion10 Nov 2025

Why it stopped: low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03348748
Sponsor's protocol ID
I 50717
Other IDs
NCI-2017-01950, I 50717
Status last verified
Mar 2026
First submitted
15 Nov 2017
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Laboratory Biomarker Analysis, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Stage I Non-Small Cell Lung Cancer AJCC v7 and Stage IA Non-Small Cell Lung Carcinoma AJCC v7, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 (time frame: Up to 10 weeks post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03348748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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