Phase 1: Systemic therapy for Brain Metastasis
To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.
Official registry: https://clinicaltrials.gov/study/NCT07655583 · M.D. Anderson Cancer Center · enrollment listed as 20
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Systemic therapy. The registry lists allocation as na. To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.
They plan to enroll about 20 people at Houston. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy
Interventions: Systemic therapy
Primary outcome (registry wording): safety and adverse events (AEs).
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Eligibility Criteria
- how well you can do daily activities (ECOG score) ≤ 2
- Brain metastasis resection occurred ≤ 5 weeks ago
- Additional prior surgeries, including Laser Interstitial Thermal Therapy (LITT), to the same or nearby location are permitted, provided that residual disease or local recurrence is confirmed pathologically at the most recent resection
- The resected lesion has never previously been targeted by radiotherapy
- Regarding prior systemic therapy:
- For participants with melanoma: no prior disease progression on any immune checkpoint inhibitor agent and ≥ 6 months between the last dose of any immune checkpoint inhibitor agent and initiation of the study systemic therapy regimen
Who the registry excludes
- History of known leptomeningeal involvement (radiographic or cytological)
- Subjects that have previously received or are currently planned for whole brain radiotherapy
- Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy
- Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled
- Participant unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast
- Pregnancy or plans to become pregnant during the duration of the study
Public study contact (from the registry)
Thomas H Beckham, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- MD Anderson Cancer Center — Houston, Texas (recruiting)
FAQ about this NCT record
Is NCT07655583 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07655583?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07655583?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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