Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors
PROMPT
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2023
CompletedStudy Start
First participant enrolled
June 9, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
April 25, 2025
April 1, 2025
3 years
June 5, 2023
April 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
local control of treated metastases at 2 years after SBRT
local control of treated metastases at 2 years after SBRT
2 years
Secondary Outcomes (5)
overall survival
2 years
progression-free survival
2 years
distant control
2 years
toxicity rates
2 years
quality of life of patients
2 years
Interventions
stereotactic body radiation therapy (SBRT)
Eligibility Criteria
Patients who underwent stereotactic body radiation therapy (SBRT) for oligometastases from 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
You may qualify if:
- 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
You may not qualify if:
- prior treatment with radiation to the same metastatic site
- inability to provide informed consent
- contraindications to SBRT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Humanitas Research Hospital
Rozzano, Milan, 20089, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 15, 2023
Study Start
June 9, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 25, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share