BridgeMD
Compares treatment options for Solid Neoplasms
Official title Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases
ClinicalTrials.gov ID: NCT07146074
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn whether radiotherapy (i.e. treatment with ionizing radiation to destroy cancer cells) can prevent symptoms in patients with metastatic cancer, having high-risk bone metastases that currently result in no or only mild symptoms.
- 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
- I1: Histologically confirmed solid tumor malignancy (with polymetastastic spread (≥ 3 metastases))
- I2: High-risk bone metastasis(es) that is (are) asymptomatic or minimally symptomatic: \ Asymptomatic or minimally symptomatic is defined as follows...
- I3: Number of Risk Factors (NRF) prognostic score 0-2
- I4: Age ≥ 18 years
- I5: Ability to provide informed consent (either by the patient or by a legally authorized representative)
You likely can't join if
- E1: Previous RT to the target treatment site(s)
- E2: NRF prognostic score 3
- E3: Serious medical co-morbidities that preclude radiotherapy
- E4: Bone lesion complicated with a pathological fracture or impending pathologic fracture for which prophylactic stabilization is recommended...
- E5: Spinal metastasis with SINS score \>13 requiring upfront neurosurgical stabilization [Fourney et al].
- E6: More than 5 high-risk asymptomatic or minimally symptomatic metastatic bone locations
See the full eligibility criteria
- I1: Histologically confirmed solid tumor malignancy (with polymetastastic spread (≥ 3 metastases))
- I2: High-risk bone metastasis(es) that is (are) asymptomatic or minimally symptomatic: \ Asymptomatic or minimally symptomatic is defined as follows: O Numeric Pain Rating Scale (NRS) score ≤2 for the specific lesion(s)...
- I3: Number of Risk Factors (NRF) prognostic score 0-2
- I4: Age ≥ 18 years
- I5: Ability to provide informed consent (either by the patient or by a legally authorized representative)
- I6: A female participant is eligible to participate if she confirms not to be pregnant at screening, and one of the following conditions applies: Is not a woman of child bearing potential or A woman of child bearing...
- E1: Previous RT to the target treatment site(s)
- E2: NRF prognostic score 3
- E3: Serious medical co-morbidities that preclude radiotherapy
- E4: Bone lesion complicated with a pathological fracture or impending pathologic fracture for which prophylactic stabilization is recommended, characterized by Mirels score of ≥9 [Mirels et al].
- E5: Spinal metastasis with SINS score \>13 requiring upfront neurosurgical stabilization [Fourney et al].
- E6: More than 5 high-risk asymptomatic or minimally symptomatic metastatic bone locations
- E7: Patient already included in another clinical trial that would interfere with the HERMES clinical trial, as assessed by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wilrijk, Antwerp, Belgium
- Aalst, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Kortrijk, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Turnhout, Belgium
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 Wilrijk, Antwerp, Belgium; Aalst, Belgium; Ghent, Belgium; Hasselt, Belgium; Kortrijk, Belgium; Leuven, Belgium and 2 more location(s). 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.