Oligometastatic DiseasePROMPTNCT05903261
Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors
An observational study of Oligometastatic Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Disease
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jun 2023to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- prior treatment with radiation to the same metastatic site
- inability to provide informed consent
- contraindications to SBRT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, Milan, 20089
Marta Scorsetti, MD PhD, +390282248524, marta.scorsetti@humanitas.it
Marta Scorsetti, MD PhD
About this study
Official title: Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors: the PROMPT Study
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.
Read the 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
- Being tested
- SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
stereotactic body radiation therapy (SBRT)
What is being measured
The primary outcome is the main question the study is designed to answer.
local control of treated metastases at 2 years after SBRT
local control of treated metastases at 2 years after SBRT
Measured: 2 years
Secondary outcomes (5)
overall survival
overall survival
Measured: 2 years
progression-free survival
time for which the patient has no trace oligometastatic progression
Measured: 2 years
distant control
analyze the formation of new metastases distant from the oligometastatic site
Measured: 2 years
toxicity rates
toxicity values caused by SBRT
Measured: 2 years
quality of life of patients
will also be assessed using validated patient-reported outcome measures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start9 Jun 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic DiseaseStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903261
- Sponsor's protocol ID
- 3497
- Acronym
- PROMPT
- Status last verified
- Apr 2025
- First submitted
- 5 Jun 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors: the PROMPT Study
- ClinicalTrials.gov ID
- NCT05903261
- Acronym / sponsor ID
- PROMPT / 3497
- Conditions
- Oligometastatic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- prior treatment with radiation to the same metastatic site
- inability to provide informed consent
- contraindications to SBRT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTstereotactic body radiation therapy (SBRT) | Radiation | – |
Primary outcome
local control of treated metastases at 2 years after SBRT
Time frame: 2 years
local control of treated metastases at 2 years after SBRT
5 secondary outcomes
overall survival
Time frame: 2 years
progression-free survival
Time frame: 2 years
distant control
Time frame: 2 years
toxicity rates
Time frame: 2 years
quality of life of patients
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligometastatic Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta MD Scorsetti (+ 39 02 8224 7454, marta.scorsetti@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local control of treated metastases at 2 years after SBRT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.