Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
NCT ID: NCT04210492
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2020-08-26
2030-01-31
Brief Summary
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Detailed Description
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The outcomes of the metastatic patients will also be reported.
There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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45 Gy
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
45 Gray (Gy) regimen
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
Interventions
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45 Gray (Gy) regimen
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
Eligibility Criteria
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Inclusion Criteria
2. ECOG Performance Status of 0-2
3. Age \> 18
4. Patients must sign a study-specific consent form.
Exclusion Criteria
* Spinal cord previously irradiated to \> 40 Gy
* Brachial plexus previously irradiated to \> 50 Gy
* Small intestine, large intestine, or stomach previously irradiated to \> 45Gy
* Brainstem previously irradiated to \> 50 Gy
* Lung previously irradiated with prior V20Gy \> 35%
2. Active systemic, pulmonary, or pericardial infection
3. Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
4. Pregnant or lactating
5. Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation
18 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Henry S. Park, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, United States
Smilow Cancer Hospital - Hamden Care Center
Hamden, Connecticut, United States
Smilow Cancer Hospital
New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center - Trumbull
Trumbull, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2000025868
Identifier Type: -
Identifier Source: org_study_id
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