Status:
UNKNOWN
SBRT Dose Escalation for Reirradiation of Inoperable Lung Lesions
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Non Small Cell Lung Cancer
Lung Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 escalat...
Detailed Description
Radical dose radiotherapy (RT) is frequently used in thoracic malignancies, both for early stage primary non-small cell lung cancer (NSCLC) and for secondary lesions from other primary tumors, particu...
Eligibility Criteria
Inclusion
- 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
- Central or ultra-central lesion(s);
- Incapability of understanding and signing informed consent.
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04455438
Start Date
May 28 2020
End Date
December 1 2025
Last Update
September 15 2022
Active Locations (1)
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1
Humanitas Research Hospital
Rozzano, Milano, Italy, 20089