Clinical trial · Interventional
Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
NCT04210492CI-TRIAL-00115016recruitingPhase 1 / Phase 2ClinicalTrials.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 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.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 45 Gray (Gy) regimen | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 45 Gy
- description
- Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
- interventionNames
- Radiation: 45 Gray (Gy) regimen
Primary outcomes (2)
- measure
- Safety of the stereotactic body radiotherapy regimen (SBRT)
- timeFrame
- From administration of SBRT up to 2 years post-SBRT
- description
- Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria
- measure
- local control (LC) of 3-fraction stereotactic body radiotherapy
- timeFrame
- Up to 10 years post-enrollment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or within 2 cm of (whether abutting or not) major vessels, esophagus, or heart (based on RTOG and MD Anderson Cancer Center definitions 33,34). Multiple concurrent isocenters are allowed if at least one tumor meets the above criteria, and if all dose constraints for the plan summation can be met. These concurrent tumors other than study target lesion can be treated as per SOC and does not necessarily have to meet the above size limit. The PI will review and prospectively approve any lesions abutting these organs. 2. ECOG Performance Status of 0-2 3. Age \> 18 4. Patients must sign a study-specific consent form. Exclusion Criteria: 1. 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% 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
References
Publications (0)
Data not yet available
No reference posted for this study.