N/A
Completed N=12
Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
Source: ClinicalTrials.gov NCT01656460 ↗Enrolled (actual)
12
Serious AEs
33.3%
Results posted
Jul 2015
Primary outcomePrimary: Early and Intermediate Toxicity for Dose Limiting Toxicity — 0; 0; 0; 0 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early and Intermediate Toxicity for Dose Limiting Toxicity |
0; 0; 0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01656460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.