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New treatment option for Metastatic Tumor
Official title A Randomized Phase III Trial of Stereotactic Ablative Radiotherapy for Patients With Up to 10 Oligometastases and a Synchronous Primary Tumor.
ClinicalTrials.gov ID: NCT05717166
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for metastatic tumor.
Also referred to as Cytotoxic Systemic Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a phase III multi-institutional randomized trial. Patients will be randomized in a 1:2 ratio between current standard of care treatment (Arm 1) vs.
- 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
- Age 18 years or older
- Willing to provide informed consent
- Karnofsky performance status \> 60
- Life expectancy \> 6 months
- Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
You likely can't join if
- Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where...
- For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator.
- Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose...
- Malignant pleural effusion
- Inability to treat all sites of disease
- Brain metastasis \> 3 cm in size or a total volume of brain metastases greater than 30 cc.
See the full eligibility criteria
- Age 18 years or older
- Willing to provide informed consent
- Karnofsky performance status \> 60
- Life expectancy \> 6 months
- Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
- Total number of metastases 1-10 at the time of enrollment, with a primary tumor also present
- Restaging completed within 12 weeks prior to randomization (see section 5.1)
- For patients receiving thoracic radiotherapy, the enrolling physician must confirm there are no computed tomography (CT) changes suggestive of fibrotic interstitial lung disease (ILD) (i.e. reticular changes, traction...
- 10 or fewer lifetime metastases from the cancer for which participants are being enrolled
- Serious medical comorbidities precluding radiotherapy. These include ILD in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, or...
- For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C); please see the Child-Pugh score calculator.
- Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously...
- Malignant pleural effusion
- Inability to treat all sites of disease
- Brain metastasis \> 3 cm in size or a total volume of brain metastases greater than 30 cc.
- Metastasis in the brainstem
- Clinical or radiologic evidence of spinal cord compression
- Metastatic disease that invades any of the following: GI tract (including esophagus, stomach, small or large bowel), or skin
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Prince George, British Columbia, Canada
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Montreal, Quebec, Canada
- Zurich, Switzerland
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 Prince George, British Columbia, Canada; Vancouver, British Columbia, Canada; London, Ontario, Canada; Montreal, Quebec, Canada; Zurich, Switzerland. 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.