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

Completed

• Conditions: Lung Cancer
• Interventions: Radiation: hypofractionated radiation therapy

• Registration Number: NCT00986297
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2009-09-26
• Study First Submitted QC: 2009-09-26
• Study First Posted: 2009-09-29
• Study Start: 2009-10
• Primary Completion: 2012-10
• Status Verified: 2014-05
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
arm one	hypofractionated radiation therapy	IGRT

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	90 days

Secondary Outcome Measures

Name	Time	Method
Local regional tumor control	6 month
Overall survival	2 year

Trial Locations

Locations (2)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Stanford University; 🇺🇸 Stanford, California, United States