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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
hypofractionated radiation therapy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

arm one

Arm Description

IGRT

Outcomes

Primary Outcome Measures

Dose-limiting toxicity

Secondary Outcome Measures

Local regional tumor control
Overall survival

Full Information

First Posted
September 26, 2009
Last Updated
August 19, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00986297
Brief Title
Specialized Radiation Therapy in Treating Patients With Stage II, Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm one
Arm Type
Other
Arm Description
IGRT
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiation therapy
Other Intervention Name(s)
IGRT
Intervention Description
hypofractionated radiation therapy
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Local regional tumor control
Time Frame
6 month
Title
Overall survival
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Timmerman, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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

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