SBRT Dose Escalation for Reirradiation of Inoperable Lung Lesions

Non Small Cell Lung Cancer Clinical Trial

— STRILL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04455438
• Other study ID #: 2525
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2020
• Est. completion date: December 2025

Study information

• Verified date: September 2022
• Source: Istituto Clinico Humanitas
• Contact: Davide Franceschini, MD
• Phone: 0039 028224 7428
• Email: davide.franceschini[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, particularly in the setting of oligometastatic patients. Although development of distant metastases is the predominant pattern of failure after treatment with radical RT, isolated local recurrences, defined as a tumor recurrence overlapping the 50% isodose field, are still observed and are becoming more and more frequent along with the prolongation of life expectancy in cancer patients. Salvage options for isolated post-radiation local failures are limited, with surgery or retreatment with radiotherapy as potential modalities.

While salvage surgical resection after previous thoracic irradiation has shown encouraging results, most patients experiencing post-radiation local relapse are not surgical candidates. Therefore, reirradiation may be the only viable salvage option for many patients. Retreatment with CFRT has been reported for locoregional failures, with generally-poor outcomes. Although, salvage SBRT after initial CFRT has been described in select small series of heterogeneous patient groups ranging from early stage to locally-advanced and metastatic, few data exist to guide us on the role of reirradiation with SBRT for isolated recurrences after initial SBRT for early-stage NSCLC. Due to the heterogeneity and the low numerosity of these experiences, important questions regarding the safety and efficacy in this setting are still largely unanswered. Particularly, the possibility of delivering a second course of ablative dose RT (BED ≥ 100 Gy) is almost unexplored.

Based on this background, we designed a 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Metastases
• Non Small Cell Lung Cancer

Intervention

Radiation:
• SBRT dose escalation
Re-Stereotactic Body Radiation Therapy (SBRT) with increasing dose levels, from 30 Gy in 5 fractions to 50 Gy in 5 fractions.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD	maximal tolerated dose (MTD) of SBRT for thoracic re-irradiation	5 years
Secondary	Other toxicities	To evaluate acute and late toxicities other than dose limiting toxicity	5 years
Secondary	Overall survival	To evaluate overall survival of patients undergoing thoracic re-irradiation.	5 years
Secondary	Local control	To evaluate local control of patients undergoing thoracic re-irradiation.	5 years
Secondary	PFS	To evaluate progression free survival of patients undergoing thoracic re-irradiation.	5 years