Study of LUNG Stereotactic Adaptive Ablative Radiotherapy (LUNG STAAR)

Baptist Health South Florida

Status: Withdrawn

Conditions: Lung Tumor; Lung Cancer

Treatments: Radiation: Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray); Radiation: Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)

Study type: Interventional

Funder types: Other

Identifiers

NCT04917224

2020-KOT-005

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cohort A: Central lung tumors

Experimental group

Description:

Gross tumor volume (GTV) less than or equal to 1 cm from a lobar bronchus

Treatment:

Radiation: Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)

Cohort B: Ultra-central lung tumors

Experimental group

Description:

Gross tumor volume (GTV) less than or equal to 1 cm from the mainstem bronchus, trachea, or esophagus

Treatment:

Radiation: Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)