title: Extracranial radiosurgery with volumetric modulated arc therapy: Feasibility evaluation of a phase I trial.
abstract: The aim of this study was to report early clinical experience in stereotactic body radiosurgery (SBRS) delivered using volumetric intensity modulated arc therapy (VMAT) in patients with primary or metastatic tumors in various extra-cranial body sites. Each enrolled subject was included in a different phase I study arm, depending on the tumor site and the disease stage (lung, liver, bone, metastatic), and sequentially assigned to a particular dose level. Technical feasibility and dosimetric results were investigated. The acute toxicity, tumor response and early local control were also studied. In total, 25 lesions in 20 consecutive patients (male/female, 11/9; median age, 67 years; age range, 47-86 years) were treated. Of these 25 lesions, 4 were primary or metastatic lung tumors, 6 were liver metastases, 8 were bone metastases and 7 were nodal metastases. The dose-volume constraints for organs at risk (OARs) were observed in 19 patients using a single-arc technique. Only in one patient were two arcs required. The treatment was performed without interruption or any other technical issues. The prescribed dose ranged from 12-26 Gy to the planning target volume (PTV). Delivery time ranged from 4 min to 9 min and 13 sec (median, 6 min and 6 sec). No incidence of grade 2-4 acute toxicity was recorded. The overall response rate was 48% (95% confidence interval (CI), 24.2-70.2) based on computed tomography (CT)/magnetic resonance imaging (MRI) and 89% (95% CI, 58.6-98.7) based on the positron emission tomography (PET) scan. SBRS delivered by means of VMAT allowed the required target coverage to be achieved while remaining within the normal tissue dose-volume constraints in the 20 consecutive patients. VMAT-SBRS resulted in adequate technical feasibility; the maximum tolerable dose has not yet been reached in any study arm.
authors.affiliation: Units of Radiotherapy, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del S. Cuore;
authors.forename: Francesco
authors.initials: F
authors.lastname: Deodato
authors.forename: Savino
authors.initials: S
authors.lastname: Cilla
authors.forename: Gabriella
authors.initials: G
authors.lastname: Macchia
authors.forename: Luciana
authors.initials: L
authors.lastname: Caravatta
authors.forename: Samantha
authors.initials: S
authors.lastname: Mignogna
authors.forename: Mariangela
authors.initials: M
authors.lastname: Massaccesi
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Picardi
authors.forename: Cinzia
authors.initials: C
authors.lastname: Digesu
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Sallustio
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Bonomo
authors.forename: Angelo
authors.initials: A
authors.lastname: Piermattei
authors.forename: Gabriella
authors.initials: G
authors.lastname: Ferrandina
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
authors.forename: Numa
authors.initials: N
authors.lastname: Cellini
authors.forename: Alessio G
authors.initials: AG
authors.lastname: Morganti
keywords: extracranial radiosurgery; feasibility; phase I; stereotactic body radiosurgery; volumetric intensity modulated arc therapy; volumetric modulated arc therapy