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New treatment option for Oligometastatic Malignant Solid Neoplasm
Official title Total RadIoTherapy of Oligometastatic caNcerS
ClinicalTrials.gov ID: NCT06587490
What this study is testing
- What it's testing
- This is a Phase III non-blinded randomized study evaluating patients with oligometastatic cancers (up to 10 metastases). Subjects are randomized 1:1 to stereotactic ablative radiotherapy (SABR) plus standard of care therapies versus standard of care therapies alone.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age at least 18 years.
- Deemed eligible to undergo standard systemic therapy and SABR to metastatic sites (i.e., patient has adequate health and life expectancy, and...
- Histopathologic confirmation of a solid malignancy.
You likely can't join if
- Pregnancy.
- Contraindications to radiotherapy, including interstitial lung disease if thoracic radiation is planned; Crohn's disease if the gastrointestinal...
- Prior radiation therapy to an area requiring treatment in the present study, if the composite dose would exceed normal tissue constraints specified...
- Malignant pleural effusion or malignant ascites.
- Leptomeningeal disease in the central nervous system.
- Metastatic disease in a site where it is not possible to safely treat with SABR to the doses specified in the trial.
See the full eligibility criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age at least 18 years.
- Deemed eligible to undergo standard systemic therapy and SABR to metastatic sites (i.e., patient has adequate health and life expectancy, and treatment is not contraindicated).
- Histopathologic confirmation of a solid malignancy.
- Newly diagnosed or progressive metastasis (at least 1 and no more than 10 discrete distant metastases visible on staging imaging. At least one metastatic lesion must be outside the brain parenchyma) for which a new line...
- New systemic therapy for metastatic disease initiated no more than 6 months prior to randomization.
- For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during active SABR treatment.
- For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during active SABR treatment.
- Pregnancy.
- Contraindications to radiotherapy, including interstitial lung disease if thoracic radiation is planned; Crohn's disease if the gastrointestinal tract will receive radiotherapy; active connective tissue disorders such...
- Prior radiation therapy to an area requiring treatment in the present study, if the composite dose would exceed normal tissue constraints specified by UC San Diego Radiotherapy Standards and Guidelines (published by the...
- Malignant pleural effusion or malignant ascites.
- Leptomeningeal disease in the central nervous system.
- Metastatic disease in a site where it is not possible to safely treat with SABR to the doses specified in the trial.
- Any unresected metastasis \>5 cm in largest diameter or \>3 cm in the brain.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.