Lung Non-Small Cell CarcinomaPhase 1NCT04073745

Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer

A Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Stereotactic Body Radiation Therapy in people with Lung Non-Small Cell Carcinoma and Positive Surgical Margin, run by Roswell Park Cancer Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Non-Small Cell Carcinoma, Positive Surgical Margin, Resected Mass
What is being tested?: Quality-of-Life Assessment, Questionnaire Administration 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: 50 participants
Where: 1 siteUnited States
Study dates: 4 Dec 2019to 11 Aug 2027
Phase: Phase 1

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 =< 2
Has completed curative-intent surgical resection of lung primary with pathologic diagnosis of NSCLC disease, with pathology to include at least 1 of the following:
Close (<=2 mm) or Positive surgical margin (R1/R2) or pathologic N2 disease (with or without extracapsular extension [ECE])
Anatomic pulmonary resection (lobectomy or pneumonectomy) preferred, although sublobar resection is allowed at the discretion of the treating surgeon. Systemic lobe-specific nodal sampling is required. A minimum of 3 N2 stations must be sampled. Selective lymph node dissection should be completed for patients with known N2 disease
Women of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence)
Patient or legal representative must be willing and able to participate in protocol requirements, including pre- and post-treatment survey evaluations and clinical assessments
Patient 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 breath reproducibly
Prior radiation therapy targeting the same area for which radiation treatment is being planned
Pregnant or nursing female patients
Unwilling or unable to follow protocol requirements
Any condition which, in the investigator?s opinion, deems the patient unable to participate in enrollment
Patients who undergo sublobar resection but are unable to undergo appropriate N1 and N2 lymph node sampling

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: A Feasibility and Toxicity Analysis of Single Fraction Stereotactic Body Radiation Therapy for Post-Operative Non-Small Cell Lung Cancer

This trial studies the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer. Standard radiation for lung cancer involves delivering small doses of daily radiation for several weeks. However, this technique has resulted in inferior outcomes compared to surgery and is associated with damage to surrounding normal lung. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving stereotactic body radiation therapy in fewer treatment sessions (single fraction) may kill tumor cells and cause less damage to normal tissue.

Read the detailed description

PRIMARY OBJECTIVES:

Assess feasibility and toxicity of single-fraction stereotactic body radiation therapy (SBRT) in the post-operative setting.

SECONDARY OBJECTIVES:

Assess quality of life following post-operative single-fraction SBRT. II. Assess rate of in-field failures.

TERTIARY OBJECTIVES:

Assess progression free survival and overall survival following post-operative SBRT for stage III/IV non-small cell lung cancer (NSCLC).

EXPLORATORY OBJECTIVES:

Changes in the inflammatory markers.

OUTLINE:

Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT.

After completion of study treatment, patients are followed up at 5 and 12 weeks and then periodically for up to 5 years.

Conditions: Lung Non-Small Cell Carcinoma, Positive Surgical Margin, Resected Mass, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8
Being tested: Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Body Radiation Therapy
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Margins of Excision, Lung Neoplasms

What participants receive

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

Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT

Study groups in NCT04073745
Study group	Role	What they receive
Treatment (SBRT)	Experimental	Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

What is being measured

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

Incidence of grade 3 or greater toxicities
Hospitalization resulting from radiation treatment will be recorded. Any acute (=< 180 days after the end of radiation therapy [RT]) and late (> 180 days after the end of RT) toxicities will be documented using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals (alpha = 0.10).
Measured: Up to 5 years
Feasibility of single fraction SBRT
Feasibility will be assessed by the median time to initiation of systemic treatment (TST) following the combination of surgery and stereotactic body radiation therapy (SBRT), as this interval will reflect the probability of completing intended treatment.
Measured: Up to 5 years

Secondary outcomes (3)

Time to initiation of systemic treatment (TST)
The proportion of patients who have TST < 8 weeks will be recorded. The median time will be presented with a 90% confidence interval (CI).
Measured: From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years
Quality of life (QoL)
The QoL scores, from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC QLQ Lung Cancer?Specific Module, and cumulative toxicity rates will be compared be at each time-point (starting 5 weeks after SBRT) between tumor locations using the Mann-Whitney U and Fishers exact tests, respectively. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test. All secondary analysis will be conducted at the 10% significance level. The QoL scores will also be examined for time trends and effects of patient characteristics using regression analysis.
Measured: Up to 5 years
In-field failure (IFF) rate
IFF rate will be reported for the total cohort and at 3- and 5-years. The IFF will be monitored using a Bayesian approach. The monitoring will start after 3 patients have received treatment.
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.

4 Dec 201911 Aug 2027

First posted29 Aug 2019
Study start4 Dec 2019
Primary completion11 Aug 2025
Study completion11 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04073745
Sponsor's protocol ID: I 81919
Other IDs: NCI-2019-04325, I 81919
Status last verified: Aug 2026
First submitted: 27 Aug 2019
Last updated: 24 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No