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

NCT04073745 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: I 81919NCI-2019-04325
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Positive Surgical Margin; Resected Mass; Stage IIIA Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Up to 5 years

Secondary Outcomes (3)

• Time to initiation of systemic treatment (TST)

  From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years

• Quality of life (QoL)

  Up to 5 years

• In-field failure (IFF) rate

  Up to 5 years

Other Outcomes (3)

• Progression free survival (PFS)

  Up to 5 years

• Overall survival (OS)

  From SBRT completion until death (event) or end of study/lost to follow-up (censored), assessed up to 5 years

• Change in immune markers

  Baseline up to 5 weeks post-SBRT

Study Arms (1)

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.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Body Radiation Therapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Treatment (SBRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SBRT)

Questionnaire Administration OTHER

Ancillary studies

Treatment (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 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

You may not qualify if:

• 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

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; Margins of Excision; Lung Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Anurag K Singh

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: December 4, 2019
• Primary Completion: August 11, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)