Specialized Radiation Therapy in Treating Patients With Stage II, Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status

NCT ID: NCT00986297

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of specialized radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent non-small cell lung cancer and poor performance status.

Detailed Description

OBJECTIVES:

Primary

• To escalate the dose of accelerated hypofractionated image-guided conformal radiotherapy to a potent tumoricidal dose without exceeding the maximum-tolerated dose in patients with recurrent or stage II-IV non-small cell lung cancer and poor performance status.

Secondary

• To evaluate local regional tumor control and overall survival of patients treated with this regimen.

OUTLINE: Patients undergo accelerated hypofractionated image-guided conformal radiotherapy once daily, 5 days a week, for 3 weeks (15 fractions). Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically for up to 5 years.

Conditions

Lung Cancer

Study Design

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

Study Groups

arm one

IGRT

Group Type: OTHER

hypofractionated radiation therapy

Intervention Type: RADIATION

hypofractionated radiation therapy

Interventions

hypofractionated radiation therapy

hypofractionated radiation therapy

Intervention Type: RADIATION

Other Intervention Names

IGRT

Eligibility Criteria

Inclusion Criteria

• No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

PATIENT CHARACTERISTICS:

• Zubrod performance status 2-4
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must agree to use effective contraception
• Must complete all required pretreatment evaluations

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 1 week since prior chemotherapy or chemoradiation therapy
• No concurrent chemotherapy
• No other concurrent antineoplastic therapy (including standard-fractionated radiotherapy to the chest, chemotherapy, biological therapy, vaccine therapy, and surgery) 1 week before, during, and for 1 week after completion of study therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert D. Timmerman, MD

Role: PRINCIPAL_INVESTIGATOR

Simmons Cancer Center

Locations

Stanford University

Stanford, California, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

SCCC-05509

Identifier Type: -

Identifier Source: secondary_id

072009-061

Identifier Type: -

Identifier Source: secondary_id

CDR0000654621

Identifier Type: -

Identifier Source: org_study_id