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

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Lung Cancer

Treatments: Radiation: hypofractionated radiation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00986297

SCCC-05509

CDR0000654621

072009-061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

  • Stage II-IV and/or recurrent disease
  • No small cell histology

• Measurable or evaluable disease

  • Tumor not amenable to surgical resection
  • Tumor not eligible for stereotactic body radiation therapy

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

arm one

Other group

Description:

IGRT

Treatment:

Radiation: hypofractionated radiation therapy