Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer (SABR)

West Virginia University

Status: Terminated

Conditions: Non Small Cell Lung Cancer

Treatments: Radiation: Image Guided Stereotactic Ablative Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02262000

WVU010513

Details and patient eligibility

About

This study will help researchers learn about the best dose of radiation to be used when treating large early stage non-small cell lung cancer (NSCLC) with a treatment called stereotactic ablative radiotherapy (SABR). Current treatments with SABR for early stage NSCLC show positive response. But, for large early stage NSCLC it may be better to give different SABR doses than what is used in routine early stage NSCLC treatment. It is not understood which dose is best for treating large early stage NSCLC. Therefore, this study can help researchers learn if giving a higher dose using SABR over a period of 5-10 treatment days can increase the chance of cure for large early stage NSCLC.

Full description

Treatment Plan:

7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT).

• Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved; but the 7.5 Gy x 10 daily fractions schedule is preferred.
• All doses are prescribed to the tumor periphery.

For this protocol, patients will be followed only up to 2 years post radiation therapy.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-Small Cell Lung Cancer
• T2N0M0 or T3(PL3)N0M0 or Locally recurrent ≤ 7 cm
• Surgically inoperable
• ECOG Performance 0-2

Exclusion criteria

• Pacemaker on the same side of the tumor
• Pregnant
• Infection that requires IV antibiotics
• Concomitant or adjuvant anti-neoplastic chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

A - 7.5 Gy x 10 daily fractions

Experimental group

Description:

Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.

Treatment:

Radiation: Image Guided Stereotactic Ablative Radiotherapy

B - 12 Gy x 5 daily fractions

Experimental group

Description:

Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved

Treatment:

Radiation: Image Guided Stereotactic Ablative Radiotherapy