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

Oligometastatic Disease Clinical Trial

— PROMPT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05903261
• Other study ID #: 3497
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: June 2026

Study information

• Verified date: June 2023
• Source: Istituto Clinico Humanitas
• Contact: Marta MD Scorsetti
• Phone: + 39 02 8224 7454
• Email: marta.scorsetti[@]hunimed.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oligometastatic Disease

Intervention

Radiation:
• SBRT
stereotactic body radiation therapy (SBRT)

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local control of treated metastases at 2 years after SBRT	local control of treated metastases at 2 years after SBRT	2 years
Secondary	overall survival	overall survival	2 years
Secondary	progression-free survival	time for which the patient has no trace oligometastatic progression	2 years
Secondary	distant control	analyze the formation of new metastases distant from the oligometastatic site	2 years
Secondary	toxicity rates	toxicity values caused by SBRT	2 years
Secondary	quality of life of patients	will also be assessed using validated patient-reported outcome measures	2 years