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

Phase 1 Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00986297

Enrollment

Registered

2009-09-29

Start date

2009-10-31

Completion date

Unknown

Last updated

2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, squamous cell lung cancer

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.

Interventions

RADIATIONhypofractionated radiation therapy

hypofractionated radiation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicity	90 days

Secondary

Measure	Time frame
Local regional tumor control	6 month
Overall survival	2 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026