Trials / Unknown
UnknownNCT05588206
Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer
Dose-escalation by Hypofractionated Stereotactic Radiotherapy Simultaneous Integrated Boost IMRT for Brain Metastases in Non Small Cell Lung Cancer：A Phase I Study
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- First People's Hospital of Hangzhou · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.
Detailed description
The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Hypofractionated Stereotactic Radiotherap | A standard 3+3 statistical design was employed. Three patients will initially be treated at dose level 1, 6 Gy in 5 fractions, 3 fractions a week. Dose limiting toxicities (DLT) were defined as any grade 3-5 radiation injury or any non-hematologic toxicity felt to be possibly, probably, or definitely related to radiation, identified within the evaluation period of 3 months following the completion of radiotherapy. |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
- First posted
- 2022-10-20
- Last updated
- 2022-10-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05588206. Inclusion in this directory is not an endorsement.