Clinical trial · Interventional
Observation for Patients With Asymptomatic CNS Metastatic Disease
NCT02866981CI-TRIAL-00032842completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this registry is to determine if select patients with CNS metastatic disease can be safely observed rather than treated. The investigators hypothesize that there is a subset of patients with small asymptomatic CNS mets that do not require treatment, these patients can simply be observed and will not have CNS progression.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Observation
- description
- Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted.
- interventionNames
- Other: Observation
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- Every two months for two years
- description
- Kaplan-Meier survival analyses
- measure
- CNS treatment-free survival rate
- timeFrame
- Every two months for two years
- description
- overall survival combined with CNS treatment
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * CNS metastatic disease that meets the following: * No lesion greater than 0.8 cm for patients not on targeted therapy with CNS penetration * No lesion greater than 1.5 cm for patients on targeted therapy with CNS penetration. * No previous treatment for the observed lesion. Patients may have had other lesions that have been treated as long as there is at least one index lesion that has not been treated. For example, patient may have had 3 lesions treated in March 2012 with radiosurgery and on recent scan is found to have a new 0.5 cm lesion, this patient is eligible. * Less than 5 untreated CNS lesions. * Able to have MRI scan with contrast * All CNS lesions are asymptomatic. Patient may have symptoms from previous treatment or cancer outside the CNS but cannot have symptoms attributable to the current CNS metastatic disease. This is left to the discretion of the treating physician and in some instances is not easy as sometimes CNS metastatic disease is incidental finding to un-related symptoms. * Eligible primaries * Lung (NSCLC) * Lung (SCLC) that have had previous Whole brain radiation * GI * Head and Neck * Gyn * Prostate * Breast * Kidney * Melanoma * Sarcoma Exclusion Criteria: * CNS lesion that does not meet following: * No lesion greater than 0.8 cm for patients not on targeted therapy with CNS penetration * No lesion greater than 1.5 cm for patients on targeted therapy with CNS penetration. * More than 5 CNS lesions (can have had previously treated lesions by either surgery or radiation, but at time of protocol SRS must have 5 or less untreated lesions). * Symptomatic CNS lesions * Ineligible primaries * Lymphoma * Primary CNS tumors * SCLC that has not had previous whole brain radiation * Leptomeningeal disease in CNS * Patients unable to have an MRI (secondary for example to metal hardware) * Patients unable to have MRI contrast (secondary for example to poor renal function * CNS lesion \>0.8 cm in any dimension for patients not on targeted therapy with CNS penetration or \>1.5 cm for patients on targeted therapy with CNS penetration. * Note that there is no KPS cut-off for eligibility
References
Publications (0)
Data not yet available
No reference posted for this study.