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 April 2016 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: April 11, 2016
Last verified: April 2016
  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 2018
Estimated Primary Completion Date: December 2016 (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

Detailed Description:

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). Poor performance status patients can be a heterogeneous group, with tumor-related factors, other co-morbidities, or advanced age placing patients in the category. These patients have traditionally been underrepresented in clinical trials, and thus no prospective study has evaluated the efficacy of other radiotherapy dose fractionations in these patients. One phase III trial of "poor-risk" locally advanced NSCLC (RTOG 93-04) included just over 40% Karnofsky performance status 60-70 patients and showed median survival times of 9.5 and 10.3 months with 60Gy of conventional radiation therapy alone or with recombinant β-interferon [18]. 1 year overall survival was just 44% in these patients.

This study includes randomization to two arms. Arm A (experimental arm) will include IGRT, 60 Gy in 15 fractions (3 weeks). Arm B will include conventional radiation, 60-66 Gy in 30-33 fractions (6 weeks) with optional concurrent with carboplatin/taxol .

The experimental arm dose for this trial is based on a dose escalation trial at University of Texas Southwestern evaluating the maximum tolerated dose of hypofractionated IGRT in this patient population (Phase I study IRB #072010-050). Doses were escalated from 3 Gy per fraction (total dose 45 Gy) to 4 Gy per fraction (total dose 60 Gy) and evaluation for treatment related toxicity was being performed. Critical structure dose constraints will be expressed as organ dose-volume limits, with limits formulated with the approval of the study investigators using known tolerance data, radiobiological conversion models, and norms used in current practice at academic centers [27].

Randomization Schema:

Patients will be allocated to the treatment using a randomized permuted block within strata to balance for patient factors other than institution. The stratifying variables are Zubrod performance status (2 vs. > 2) and stage (II vs. III).

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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

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: April 11, 2016
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 July 26, 2016