Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified October 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01459497
First received: October 19, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction).


Condition Intervention Phase
Non-small Cell Lung Cancer
Radiation: Radiation Therapy
Radiation: Conventional radiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Standard Versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer and Poor Performance Status

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Efficacy of overall survival of standard radiation versus accelerated, hypofractionated, image-guided conformal radiotherapy in treatment of stage II-III NSCLC in patients with poor performance status [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicities of two radiotherapy treatment regimens in patients with stage II-III NSCLC and poor performance status [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Time to local progression of two radiotherapy treatment regimens in patients with stage II-III NSCLC and poor performance status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Disease-free survival of two radiotherapy treatment regimens in patients with stage II-III NSCLC and poor performance status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life of two radiotherapy treatment regimens in patients with stage II-III NSCLC and poor performance status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cost effectiveness of two radiotherapy treatment regimens in patients with stage II-III NSCLC and poor performance status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality adjusted life of two radiotherapy treatment regimens in patients with stage II-III NSCLC and poor performance status [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiation Therapy
Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks
Radiation: Radiation Therapy
Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks
Active Comparator: Conventional Radiation
Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks
Radiation: Conventional radiation
Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients must be willing and capable to provide informed consent to participate in the protocol.
  • Patients must have appropriate staging studies identifying them as AJCC stage II or III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix III), or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology within 6 months of study entry.
  • Patients must have the potential for benefit from local therapy (at the discretion of the investigator).
  • The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod performance status 0-1 and weight loss >10% are considered eligible. In addition, patients determined to be medically unfit or refusing combined modality therapy are eligible.
  • Age ≥ 18.
  • Patients must have measurable or evaluable disease.
  • Women of childbearing potential and male participants must agree to use an effective method of contraception.
  • Patients must sign study specific informed consent prior to study entry.
  • Patients must not have plans for concurrent chemoradiation therapy.
  • Patients must complete all required pretreatment evaluations

Exclusion Criteria:

  • Total (aggregate) gross tumor volume > 500 cm3 (500 cc's or 0.5 Liters)
  • Prior radiotherapy to the region of the study cancer that would result in direct overlap of radiation therapy fields.
  • Chemotherapy given within one week of study registration.
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459497

Contacts
Contact: Robert Timmerman, MD 214-645-7651
Contact: Jean Wu, MSN 214-633-1753 jean.wu@utsouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert Timmerman, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01459497     History of Changes
Other Study ID Numbers: STU 052011-093
Study First Received: October 19, 2011
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
non-small cell lung cancer
Stages II or III non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014