Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors

NCT ID: NCT05903261

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2026-06-30

Brief Summary

This prospective observational study aims to investigate the effectiveness and safety of SBRT in the management of oligometastases from rare tumors. In addition, the study aims to identify potential differences in treatment efficacy and toxicity between different types of cancer and to provide valuable information on the use of SBRT in these contexts, potentially leading to better treatment options and outcomes for these patients.

Detailed Description

Oligometastases, defined as limited number of metastases (commonly from one up to five), are increasingly recognized as a distinct clinical entity in cancer management. Recently, the collaboration of experts from ESTRO and EORTC societies elaborated a consensus document and recommended a classification of oligometastatic patients into specific subcategories, according to 17 disease characterization factors and 5 different questions. Emerging evidence suggests that local treatment of oligometastases with stereotactic body radiation therapy (SBRT) can achieve excellent local control with minimal toxicity.

Indeed, the majority of clinical trials investigating the use of SBRT for oligometastases have focused on common solid tumors. There is limited data on the use of SBRT for oligometastases from rare primary tumors such as melanoma, soft tissue sarcoma, head-neck tumors, gynaecological tumors, Merkel cell carcinoma, thymic carcinoma, gastrointestinal stromal tumors (GIST) and urothelial tumors. Additionally, patients with rare tumors often have limited treatment options, and thus, the use of metastases-directed SBRT may provide a potential curative treatment option for these patients.

The use of SBRT for oligometastases from rare tumors is promising, as local control rates have been reported to be high, and the toxicity profile favorable. Additionally, patients with rare tumors often have limited treatment options, and thus, the use of metastases-directed SBRT may provide a potential curative treatment option for these patients. By investigating multiple rare tumor types within one trial, this study aims to identify potential differences in treatment efficacy and toxicity among the different tumor types, and to provide valuable insights into the use of SBRT in this setting, potentially leading to improved treatment options and outcomes for these patients.

Conditions

Oligometastatic Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

SBRT

stereotactic body radiation therapy (SBRT)

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• ECOG PS 0 - 2
• histologically confirmed diagnosis of rare solid tumors including melanoma, soft tissue sarcoma, head-neck tumors, gynaecological tumors, Merkel cell carcinoma, thymic carcinoma, gastrointestinal stromal tumors (GIST) and urothelial tumors
• No limit to the number of metastases treated with SBRT but all active lesions must be treated with radical intent (primary tumor and metastases)
• Synchronous and metachronous oligometastases, as well as oligorecurrent and oligoprogressive disease are allowed
• Ablative dose intended as a minimum dose of 50Gy EQD2/10 in a maximum of 10 fractions
• No restrictions to prior or on-going systemic therapies

Exclusion Criteria

• prior treatment with radiation to the same metastatic site
• inability to provide informed consent
• contraindications to SBRT

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Research Hospital

Rozzano, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marta MD Scorsetti

Role: CONTACT

marta.scorsetti@hunimed.eu

+ 39 02 8224 7454

Ciro MD Franzese

Role: CONTACT

ciro.franzese@hunimed.eu

+ 39 02 8224 7454

Facility Contacts

Marta Scorsetti, MD PhD

Role: primary

marta.scorsetti@humanitas.it

+390282248524

Other Identifiers

3497

Identifier Type: -

Identifier Source: org_study_id