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Tests treatment safety and results for Metastatic Cancer
Official title A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer.
ClinicalTrials.gov ID: NCT06363773
What this study is testing
- What it's testing
- This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression. In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7).
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
- Male or female, 18 years of age or older,
- Patient with a metastatic solid tumor,
- Patient with at least one target lesion (for radiotherapy) together with other secondary lesions that must be measurable,
- Measurable disease according to RECIST 1.1 and iRECIST criteria,
- Patient undergoing anti-PD1 immunotherapy as part of standard of care treatment,
You likely can't join if
- Patient having received previous radiotherapy since the start of immunotherapy,
- Patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage),
- Patient with an active implantable medical device (e.g. pacemaker) or an active medical device worn on the body that could interact adversely with...
- Patient with hematological cancer,
- Symptomatic patient requiring a rapid change of systemic line according to the investigator's judgment,
- Concurrent participation in another clinical trial, or patient having received an investigational product within 30 days prior to inclusion,
See the full eligibility criteria
- Male or female, 18 years of age or older,
- Patient with a metastatic solid tumor,
- Patient with at least one target lesion (for radiotherapy) together with other secondary lesions that must be measurable,
- Measurable disease according to RECIST 1.1 and iRECIST criteria,
- Patient undergoing anti-PD1 immunotherapy as part of standard of care treatment,
- Disease progression with immunotherapy (progression assessed by iRECIST criteria) but having received at least 6 months of immunotherapy,
- Performance Status (PS) of 0 or 1,
- Patient eligible for stereotactic radiotherapy,
- Patient affiliated to or benefiting from a social security scheme,
- Patient having been informed of the investigation and having signed the informed consent form prior to any study-specific procedures,
- Patient willing and able to undergo all examinations and procedures in accordance with the clinical investigation plan.
- Patient having received previous radiotherapy since the start of immunotherapy,
- Patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage),
- Patient with an active implantable medical device (e.g. pacemaker) or an active medical device worn on the body that could interact adversely with stereotactic radiotherapy treatment,
- Patient with hematological cancer,
- Symptomatic patient requiring a rapid change of systemic line according to the investigator's judgment,
- Concurrent participation in another clinical trial, or patient having received an investigational product within 30 days prior to inclusion,
- Pregnant or breast-feeding women,
- Patient under legal protection.
The study team makes the final eligibility decision.
Where it's taking place
- Soyaux, Charente, France
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 Soyaux, Charente, France. 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.