Clinical trial NCT04073745: Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer
Official title: A Feasibility and Toxicity Analysis of Single Fraction Stereotactic Body Radiation Therapy for Post-Operative Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
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
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of grade 3 or greater toxicities
timeFrame: Up to 5 years
measure: Feasibility of single fraction SBRT
timeFrame: Up to 5 years
Secondary outcomes:
measure: Time to initiation of systemic treatment (TST)
timeFrame: From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years
measure: Quality of life (QoL)
timeFrame: Up to 5 years
measure: In-field failure (IFF) rate
timeFrame: Up to 5 years
Other outcomes:
measure: Progression free survival (PFS)
timeFrame: Up to 5 years
measure: Overall survival (OS)
timeFrame: From SBRT completion until death (event) or end of study/lost to follow-up (censored), assessed up to 5 years
measure: Change in immune markers
timeFrame: Baseline up to 5 weeks post-SBRT
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag K Singh
role: PRINCIPAL_INVESTIGATOR
References: