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

NCT ID: NCT02262000

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-07-10

Brief Summary

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.

Detailed 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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A - 7.5 Gy x 10 daily fractions

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

Group Type: EXPERIMENTAL

Image Guided Stereotactic Ablative Radiotherapy

Intervention Type: RADIATION

B - 12 Gy x 5 daily fractions

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

Group Type: EXPERIMENTAL

Image Guided Stereotactic Ablative Radiotherapy

Intervention Type: RADIATION

Interventions

Image Guided Stereotactic Ablative Radiotherapy

Intervention Type: RADIATION

Other Intervention Names

SABR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Mattes, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

West Virginia University Hospitals Mary Babb Randolph Cancer Center

Morgantown, West Virginia, United States

Countries

United States

References

Levy A, Guckenberger M, Hurkmans C, Nestle U, Belderbos J, De Ruysscher D, Faivre-Finn C, Le Pechoux C. SBRT Dose and Survival in Non-Small Cell Lung Cancer: In Regard to Koshy et al. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):945-6. doi: 10.1016/j.ijrobp.2015.03.032. No abstract available.

Reference Type: DERIVED

PMID: 26104945 (View on PubMed)

Other Identifiers

WVU010513

Identifier Type: -

Identifier Source: org_study_id