Phase I Trial Evaluating Stereotactic Body Radiotherapy (SBRT) Dose Escalation for Reirradiation of Inoperable Lung Lesions

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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 escalation planned in this study is the delivery of an ablative dose to radically treat patients with inoperable local relapse, without unacceptable toxicity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Humanitas Research Hospital
RECRUITING
Rozzano
Contact Information
Primary
Davide Franceschini, MD
davide.franceschini@gmail.com
0039 028224 7428
Backup
Federico Fornasier, M.Sc
federico.fornasier@gmail.com
0039 028224 7026
Time Frame
Start Date: 2020-05-28
Estimated Completion Date: 2025-12
Participants
Target number of participants: 15
Treatments
Experimental: SBRT Level 1
The starting dose level will be SBRT 30 Gy in 5 fractions (level 1 or L1).
Experimental: SBRT Level 2
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)
Experimental: SBRT Level 3
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)
Sponsors
Leads: Istituto Clinico Humanitas

This content was sourced from clinicaltrials.gov