Clinical trial · Interventional
Phase I Dose Escalation in Patients With 1-3 Unresectable Brain Metastases
Study Phase I Dose Escalation With Hypofractionated Stereotactic Radiotherapy in Patients With 1-3 Unresectable Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low rate of recruitment.
Summary
Brief summary (as posted)
Brain metastases occur in 20-40% of patients with metastatic cancer. The standard treatment is based on whole brain radiation therapy and local treatment of metastases as neurosurgery or radiosurgery. However, many cases can not receive a standard local treatment, and local relapse occurs in almost 50% of cases treated with only whole brain irradiation. There are retrospective studies of increased radiation dose at the site of metastasis with hypofractionated stereotactic radiotherapy (HSRT) with favorable results, but there are no controlled studies regarding the safety of radiation dose in these situations. This study is a phase I study to evaluate the maximum tolerance dose (MTD) with HSRT as a way to increase the dose of radiation after the WBRT for patients with 1-3 brain metastases not eligible for surgery or RS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4fx x 5Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HSRT - 4fx x 5 Gy
- description
- It'll be recruited 3 patients to the initial regimen of four fractions of 5 Gy on each brain metastasis with HSRT and if no patient has unacceptable toxicity, more 3 patients for subsequent scheme will be recruited. If 2 patients had unacceptable toxicity, the study ends and it'll be considered that the study was initiated with toxic regimen. If 1 patient has unacceptable toxicity, it'll be recruited 3 more patients for this scheme and if 1 or more patients had unacceptable toxicity, the scheme will be considered toxic and the study will be closed. If no patient develops unacceptable toxicity, the study will follow to the next cohort of 3 more patients with the next dose level.
- interventionNames
- Radiation: 4fx x 5Gy
Primary outcomes (1)
- measure
- Maximum Tolerance Dose
- timeFrame
- Always after 3 patients recruited (up to 30 days after completion of radiotherapy planned)
- description
- To establish the MTD with HSRT as a way to increase the dose of radiation after the WBRT for patients with 1-3 brain metastases not eligible for surgery or RS, and find the dose for phase II study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with 1-3 brain metastases with histological diagnosis of malignancy and ineligible for surgery or RS * Age ≥18 years * Karnofsky Performance Status (KPS) ≥ 70% * "Status" of neurological function: zero to 3 * Anticipated survival \> 3 months * Informed consent for this research signed Exclusion Criteria: * Prior brain irradiation for any reason * Indian race * Primary tumor of lymphoma, leukemia, germ cell, small cell carcinoma or central nervous system * Leptomeningeal dissemination * single or multiple metastases with surgical (patients with KPS ≥ 70, with metastatic site in an area not eloquent or herniation causing mass effect or hydrocephalus) or RS indication(patients with KPS ≥ 70 and metastatic lesion \<4 cm in diameter with distance to chiasm, tract and optic nerves, and brain stem \> 5 mm) * Inability to have MRI * Patients who have undergone prior treatment for specific brain metastases (eg surgery, RS, chemotherapy), excluding corticosteroids * People with mental incapacity * People in a relationship of dependence as prisoners, soldiers, students, staff, etc..
References
Publications (0)
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