Clinical trial · Interventional
Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer
NCT01656460CI-TRIAL-00046089completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic radiation Arm 1 | Radiation | — | UNRESOLVED |
| Stereotactic radiation Arm 2 | Radiation | — | UNRESOLVED |
| Stereotactic radiation Arm 3 | Radiation | — | UNRESOLVED |
| Stereotactic radiation Arm 4 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Stereotactic radiation Arm 1
- description
- Dose Levels/total Dose 1 16 Gy
- interventionNames
- Radiation: Stereotactic radiation Arm 1
- type
- EXPERIMENTAL
- label
- Stereotactic radiation Arm 2
- description
- 2 20 Gy
- interventionNames
- Radiation: Stereotactic radiation Arm 2
- type
- EXPERIMENTAL
- label
- Stereotactic radiation Arm 3
- description
- 3 24 Gy
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.