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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 24, 2014
Last verified: July 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 24, 2014
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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014