Status:
COMPLETED
Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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 po...
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 po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01459497
Start Date
October 1 2012
End Date
October 19 2023
Last Update
January 17 2024
Active Locations (7)
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1
Georgetown Cancer Center (Austin Cancer Center)
Austin, Texas, United States, 78758
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
3
Md Anderson Cancer Center
Houston, Texas, United States, 77030
4
Baylor Research Institute Dallas, Baylor Irving
Irving, Texas, United States, 75061