Study of LUNG Stereotactic Adaptive Ablative Radiotherapy

Baptist Health South Florida

Overview

The proposed study expands on the principles of SBRT (Stereotactic Body Radiation Therapy) and SABR (Stereotactic Ablative Radiotherapy) for centrally located NSCLC (Non-Small Cell Lung Cancer) to further optimize outcomes in this patient population with utilization of the adaptive workflow to maintain tumor control rates but decrease the incidence and grade of treatment-related toxicities.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Lung Cancer Lung Tumor

Interventions

Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)RADIATION

Cohort A will include 30 patients with central tumors; the dose regimen prescribed is 50 Gy (Gray) in 5 fractions with a 40 hour inter-fraction interval.

Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)RADIATION

Cohort B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years of age * Clinical diagnosis of NSCLC * Stage T1-2b (≤ 5 cm) Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (i.e., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 1 year is permitted; * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Prior chemotherapy for the study cancer * Plans for the patient to receive other local therapy (including standard fractionated radiotherapy and/or surgery) while on this study, except at disease progression * Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression

Outcomes

Primary Outcomes

Treatment completion

Number of patients who completed treatment within +/- 5 days of intended treatment.

Time frame: Plus or minus 5 days of treatment

Number of patients experiencing adverse events

No greater than 15 percent of patients experience a 12-month ≥ grade 3 toxicity and ≤1 grade 5 toxicity possibly, probably, or definitely related to treatment.

Time frame: 12-month of treatment

Secondary Outcomes

Primary Tumor Control Rate

Primary tumor control rate at the maximum tolerated dose (MTD) based on each treatment cohort.

Time frame: 1 year of treatment

Progression-free survival (PFS)

Progression-free survival (PFS) is defined as the first occurrence of local and/or regional disease progression, distant metastases, second primary tumor, or death due to any cause. PFS time is measured from the date of start of SBRT to the date of the failure event for PFS.

Time frame: 1 year of treatment

Overall survival (OS)

Overall survival (OS) time is measured from the date of start of SBRT to the date of death due to any cause.

Time frame: 1 year of treatment

Functional Assessment of Cancer Therapy - Lung (FACT-L)

The Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life instrument has been extensively used for measuring quality of life in patients with lung cancer. There are 5 sections dealing with physical, family, emotional, functional well-being, and additional concerns. There are nine questions that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI (Trial Outcome Index) is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale.

Data from ClinicalTrials.gov

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