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New treatment option for Non-small Cell Lung Cancer
Official title Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
ClinicalTrials.gov ID: NCT04210492
What this study is testing
- What it's testing
- The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal...
- ECOG Performance Status of 0-2
- Age \> 18
- Patients must sign a study-specific consent form.
You likely can't join if
- Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures...
- 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%
See the full eligibility criteria
- Lung tumors will be ≤ 5 cm and centrally located, meaning any portion of gross tumor volume located within 2 cm of (but not abutting) the proximal bronchial tree (trachea, carina, right and left main bronchi, right and...
- ECOG Performance Status of 0-2
- Age \> 18
- Patients must sign a study-specific consent form.
- Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in \<3Gy per fraction):
- 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%
- Active systemic, pulmonary, or pericardial infection
- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- Pregnant or lactating
- Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation
The study team makes the final eligibility decision.
Where it's taking place
- Greenwich, Connecticut, United States
- Guilford, Connecticut, United States
- Hamden, Connecticut, United States
- New Haven, Connecticut, United States
- Trumbull, Connecticut, United States
- Waterford, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greenwich, Connecticut, United States; Guilford, Connecticut, United States; Hamden, Connecticut, United States; New Haven, Connecticut, United States; Trumbull, Connecticut, United States; Waterford, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.