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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05903261
Acronym
PROMPT
Enrollment
200
Registered
2023-06-15
Start date
2023-06-09
Completion date
2026-06-30
Last updated
2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oligometastatic Disease

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.

Interventions

RADIATIONSBRT

stereotactic body radiation therapy (SBRT)

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
local control of treated metastases at 2 years after SBRT2 yearslocal control of treated metastases at 2 years after SBRT

Secondary

MeasureTime frameDescription
overall survival2 yearsoverall survival
progression-free survival2 yearstime for which the patient has no trace oligometastatic progression
distant control2 yearsanalyze the formation of new metastases distant from the oligometastatic site
toxicity rates2 yearstoxicity values caused by SBRT
quality of life of patients2 yearswill also be assessed using validated patient-reported outcome measures

Countries

Italy

Contacts

Primary ContactMarta MD Scorsetti
marta.scorsetti@hunimed.eu+ 39 02 8224 7454
Backup ContactCiro MD Franzese
ciro.franzese@hunimed.eu+ 39 02 8224 7454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026