Escalating SBRT doses for re-treating inoperable lung tumors

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

This study is testing whether giving higher doses of a special type of radiation therapy can safely help people with inoperable lung tumors that have come back after previous treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituto Clinico Humanitas (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Rozzano, Milano)
• Trial ID: NCT04455438 on ClinicalTrials.gov

What this trial studies

This prospective phase I study aims to evaluate the maximum tolerated dose (MTD) of stereotactic body radiation therapy (SBRT) for re-irradiation of inoperable lung lesions, specifically targeting non-small cell lung cancer and lung metastases. The study focuses on patients who have previously undergone radical dose radiotherapy and are experiencing local recurrences. By escalating the dose of SBRT, the researchers hope to deliver an ablative treatment while minimizing the risk of severe toxicity, particularly pneumonitis. The study will assess the safety and efficacy of this approach in a controlled setting.

Who should consider this trial

Good fit: Ideal candidates include patients with inoperable primary non-small cell lung cancer or lung metastases who have previously received radical radiotherapy.

Not a fit: Patients with central or ultra-central lung lesions or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with inoperable lung lesions, potentially improving their outcomes and quality of life.

How similar studies have performed: While there have been limited reports on salvage SBRT after initial conventional radiotherapy, this specific approach to reirradiation with dose escalation is relatively novel and not extensively tested.

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.

Where this trial is running

Rozzano, Milano

• Humanitas Research Hospital — Rozzano, Milano, Italy (Recruiting)

Study contacts

• Study coordinator: Davide Franceschini, MD

Conditions Non Small Cell Lung Cancer; Lung Metastases