Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- local control of treated metastases at 2 years after SBRT
- timeFrame
- 2 years
- description
- local control of treated metastases at 2 years after SBRT
Secondary outcomes (5)
- measure
- overall survival
- timeFrame
- 2 years
- description
- overall survival
- measure
- progression-free survival
- timeFrame
- 2 years
- description
- time for which the patient has no trace oligometastatic progression
- measure
- distant control
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available