Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.
Checked against the public recordLast updated Jul 22, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Dr Thomas DiPetrillo
- Interventions being studied
- Radiation: Stereotactic radiation Arm 1; Radiation: Stereotactic radiation Arm 2; Radiation: Stereotactic radiation Arm 3; Radiation: Stereotactic radiation Arm 4
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion) * Pathologically or cytologically confirmed NSCLC * Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible. * Concurrent chemoradiation to a radiation dose of 50.4 Gy. * residual tumor volume after concurrent chemoradiation that is appropriate for SBRT: * Primary tumor \<120cc (approximately 6cm diameter). * Mediastinal/Hilar disease: 1-2 involved regions \<60cc (approximately 5cmx3cmx3cm) * Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL. * Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN. * ECOG performance status 0 to 2 * Minimum life expectancy of 12 weeks. * Age older than 18 years. * Voluntary, signed written informed consent. * Women of childbearing potential must have a negative pregnancy test * Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter. Conditions for Patient Ineligibility (Exclusion) * Disease progression during or after standard chemoradiation to 50.4 Gy * Prior thoracic radiation other than the pre-operative radiation not greater than 50.4 * Metastatic disease * Uncontrolled severe, intercurrent illness. * Women who are breast-feeding. * No chemotherapy within 2 weeks from the first SBRT treatment. * Concurrent anticancer therapy. * Prior complete resection of all NSCLC.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- memorial Hospital of Rhode islandPawtucket, Rhode Island
- Rhode Island HospitalProvidence, Rhode Island
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2020. Always confirm current availability with the study team.