Observational study of SBRT for patients with rare tumors and oligometastases
Prospective Observational Basket Study of Stereotactic Body Radiation Therapy for OligoMetastatic Patients From Rare Tumors: the PROMPT Study
Istituto Clinico Humanitas · NCT05903261
This study is testing how well a special type of radiation therapy works for patients with rare tumors that have spread to a few other places in the body.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Rozzano, Milan) |
| Trial ID | NCT05903261 on ClinicalTrials.gov |
What this trial studies
This prospective observational study investigates the effectiveness and safety of stereotactic body radiation therapy (SBRT) in managing oligometastases from rare tumors. It aims to identify differences in treatment efficacy and toxicity across various cancer types, providing valuable insights into SBRT's role in these contexts. The study includes patients with a limited number of metastases and evaluates the potential for improved treatment outcomes through localized radiation therapy. By focusing on rare tumors, this research seeks to enhance treatment options for patients who often face limited choices.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed rare solid tumors and oligometastases who meet specific eligibility criteria.
Not a fit: Patients who have previously received radiation treatment to the same metastatic site or have contraindications to SBRT may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a promising treatment option for patients with rare tumors and oligometastases, potentially leading to better local control and outcomes.
How similar studies have performed: While there is limited data on SBRT for rare tumors, previous studies have shown promising results for SBRT in common solid tumors, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rozzano, Milan
- Humanitas Research Hospital — Rozzano, Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Marta MD Scorsetti
- Email: marta.scorsetti@hunimed.eu
- Phone: + 39 02 8224 7454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oligometastatic Disease