Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

Summary

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I non-small cell lung cancer.

Conditions

• Lung Cancer

Interventions

RADIATION

SBRT 40.0 Gy

SBRT delivered in 5 fractions of 8.0 Gy/fraction over 1.5 to 2 weeks for a total of 40.0 Gy

RADIATION

SBRT 42.5 Gy

SBRT delivered in 5 fractions of 8.5 Gy/fraction over 1.5 to 2 weeks for a total of 42.5 Gy

RADIATION

SBRT 45.0 Gy

SBRT delivered in 5 fractions of 9.0 Gy/fraction over 1.5 to 2 weeks for a total of 45.0 Gy

RADIATION

SBRT 47.5 Gy

SBRT delivered in 5 fractions of 9.5 Gy/fraction over 1.5 to 2 weeks for a total of 47.5 Gy

RADIATION

SBRT 50.0 Gy

SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy

RADIATION

SBRT 52.5 Gy

SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy

RADIATION

SBRT 55.0 Gy

SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy

RADIATION

SBRT 57.5 Gy

SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy

RADIATION

SBRT 60.0 Gy

SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• NRG Oncology

  collaborator OTHER

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Andrea Bezjak, MD, MSC, FRCPC · Princess Margaret Hospital, Canada

• Jeffrey Bradley, MD · Mallinckrodt Institute of Radiology at Washington University Medical Center

• Laurie E. Gaspar, MD, MBA · University of Colorado, Denver

• Robert D. Timmerman, MD · University of Texas

• Elizabeth Gore, MD · Medical College of Wisconsin

• Feng-Ming Phoenix Konb, MD, PhD · Georgia Regents University Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2014-09-30

Completion

2022-05-20

Countries

• United States
• Canada

Study Locations