Clinical trial · Interventional
SBRT Dose Escalation for Reirradiation of Inoperable Lung Lesions
Phase I Trial Evaluating Stereotactic Body Radiotherapy (SBRT) Dose Escalation for Reirradiation of Inoperable Lung Lesions
NCT04455438CI-TRIAL-00060871STRILLunknownN/AClinicalTrials.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)
Prospective phase I study to evaluate the maximum tolerated dose (MTD) of SBRT for thoracic re-irradiation. Dose limiting toxicity will be pneumonitis ≥ G3. The potential advantage of the dose escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local relapse, without unacceptable toxicity.
Conditions
Conditions (2)
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 Metastases | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT dose escalation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SBRT Level 1
- description
- The starting dose level will be SBRT 30 Gy in 5 fractions (level 1 or L1).
- interventionNames
- Radiation: SBRT dose escalation
- type
- EXPERIMENTAL
- label
- SBRT Level 2
- description
- If the starting dose is tolerated in the first 5 patients, the next dose will be SBRT 40 Gy in 5 fractions (level 2 or L2)
- interventionNames
- Radiation: SBRT dose escalation
- type
- EXPERIMENTAL
- label
- SBRT Level 3
- description
- If the second dose is tolerated in the next 5 patients, the next dose will be SBRT 50 Gy in 5 fractions (level 3 or L3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inoperable primary non-small cell lung cancer or other metastatic primaries with lung metastases, already treated with radical dose RT; * Peripheral lesion (\> 2 cm from trachea-bronchial tree); * Inoperable local recurrence (defined as a tumor recurrence overlapping the 50% isodose field) confirmed by documented radiographic findings and/or pathological biopsies within the thoracic area; * Patients had previously received curative intent RT of more than 50 Gy for conventionally fractionated RT or a biologically equivalent dose of more than 75 Gy for SBRT; * No active distant metastasis or controlled distant metastasis at the time of re-irradiation Exclusion Criteria: * Central or ultra-central lesion(s); * Incapability of understanding and signing informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.