Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified November 2012 by University of Texas Southwestern Medical Center
Sponsor:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01459497
First received: October 19, 2011
Last updated: November 19, 2012
Last verified: November 2012
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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 2016 |
| Estimated Primary Completion Date: | December 2014 (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: | November 19, 2012 |
| 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 May 19, 2013