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

Roswell Park Comprehensive Cancer Center

Status and phase: Active, not recruiting; Phase 1

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04073745

I 81919 (Other Identifier)

NCI-2019-04325 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

TERTIARY OBJECTIVES:

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

EXPLORATORY OBJECTIVES:

I. 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Treatment (SBRT)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Radiation: Stereotactic Body Radiation Therapy

Other: Questionnaire Administration