Lung Cancer Clinical Trial
Official title:
Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
Verified date | December 2019 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due to side effects.
Status | Terminated |
Enrollment | 30 |
Est. completion date | July 19, 2016 |
Est. primary completion date | July 19, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Histologically or cytologically documented NSCLC, SCLC, thymic tumors, or carcinoid tumors 2. Patients not receiving concurrent chemotherapy 3. Patients that are eligible for concurrent treatment with biologic agents (epidermal growth factor receptor [EGFR] or vascular endothelial growth factor [VEGF] inhibitors) will be eligible for the study. Exclusion Criteria: 1. Prior radiotherapy to the chest 2. Life expectancy <6 months 3. Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy | Dose-limiting toxicity (DLT) defined as any CTCAE v4.0 grade 4 complication of esophagus or skin, or any grade 3 or higher complications of other organ systems (i.e. lung, liver, kidney, or GI tract), unless these complications are deemed to be related to those of esophagus. DLT assessed within 1 month of completion of radiation therapy. MTD defined as highest dose for which probability of toxicity is closest to 25%. | 1 month after completion of radiation therapy |
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