SBRT Dose Escalation for Reirradiation of Inoperable Lung Lesions
Launched by ISTITUTO CLINICO HUMANITAS · Jul 1, 2020
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a type of treatment called Stereotactic Body Radiation Therapy (SBRT) to see how much radiation can be safely given to patients with lung cancer that cannot be surgically removed. The goal is to find the highest dose that can be given without causing serious side effects, particularly a condition called pneumonitis, which is inflammation of the lungs. This study is important because it aims to provide a stronger treatment option for patients who have had a recurrence of their lung cancer after previous radiation therapy.
To participate in this trial, patients should have inoperable non-small cell lung cancer or lung metastases, meaning the cancer has spread to their lungs from another area but cannot be removed with surgery. Eligible participants should have had prior radiation treatment and have a specific type of tumor that is not close to major airways. The trial is currently recruiting patients aged between 65 and 74, and those interested will be guided through the process to ensure they understand all aspects before consenting to join. Overall, participants can expect close monitoring during the trial to track any side effects and the effectiveness of the treatment.
Gender
ALL
Eligibility criteria
- 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.
About Istituto Clinico Humanitas
Istituto Clinico Humanitas is a leading clinical research organization based in Italy, dedicated to advancing medical science through innovative clinical trials and research initiatives. With a strong emphasis on patient-centered care and cutting-edge methodologies, the institute collaborates with various stakeholders in the healthcare sector to develop and evaluate new therapies and treatment protocols. Its multidisciplinary team of experts is committed to ensuring the highest standards of ethical practice and scientific rigor, contributing to significant advancements in medical knowledge and improved patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rozzano, Milano, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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