Last updated: January 12, 2024
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed
Phase
3
Condition
Non-small Cell Lung Cancer
Treatment
Conventional radiation
Radiation Therapy
Clinical Study ID
NCT01459497
STU 052011-093
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- All patients must be willing and capable to provide informed consent to participate inthe protocol.
- Patients must have appropriate staging studies identifying them as AJCC stage II orIII non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendixIII), or recurrent non small cell lung cancer. Histologic confirmation of cancer willbe required by biopsy or cytology within 6 months of study entry.
- Patients must have the potential for benefit from local therapy (at the discretion ofthe investigator).
- The patient's Zubrod performance status must be 2 or greater OR patients with Zubrodperformance status 0-1 and weight loss >10% are considered eligible. In addition,patients determined to be medically unfit or refusing combined modality therapy areeligible.
- Age ≥ 18.
- Patients must have measurable or evaluable disease.
- Women of childbearing potential and male participants must agree to use an effectivemethod 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
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 directoverlap of radiation therapy fields.
- Chemotherapy given within one week of study registration.
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryoor fetus.
Study Design
Total Participants: 103
Treatment Group(s): 2
Primary Treatment: Conventional radiation
Phase: 3
Study Start date:
October 01, 2012
Estimated Completion Date:
October 19, 2023
Study Description
Connect with a study center
Georgetown Cancer Center (Austin Cancer Center)
Austin, Texas 78758
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Md Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Baylor Research Institute Dallas, Baylor Irving
Irving, Texas 75061
United StatesSite Not Available
Texas Oncology - Sherman
Sherman, Texas 75090
United StatesSite Not Available
Scott & White Memorial Temple
Temple, Texas 76508
United StatesSite Not Available
Texas Oncology - Tyler
Tyler, Texas 75702
United StatesSite Not Available
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