Recruitment

Recruitment Status
Withdrawn

Inclusion Criterias

"Status" of neurological function: zero to 3
Patients with 1-3 brain metastases with histological diagnosis of malignancy and ineligible for surgery or RS
Informed consent for this research signed
...
"Status" of neurological function: zero to 3
Patients with 1-3 brain metastases with histological diagnosis of malignancy and ineligible for surgery or RS
Informed consent for this research signed
Age ≥18 years
Anticipated survival > 3 months
Karnofsky Performance Status (KPS) ≥ 70%

Exclusion Criterias

People with mental incapacity
Inability to have MRI
Indian race
...
People with mental incapacity
Inability to have MRI
Indian race
Prior brain irradiation for any reason
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)
Patients who have undergone prior treatment for specific brain metastases (eg surgery, RS, chemotherapy), excluding corticosteroids
Leptomeningeal dissemination
People in a relationship of dependence as prisoners, soldiers, students, staff, etc..
Primary tumor of lymphoma, leukemia, germ cell, small cell carcinoma or central nervous system

Summary

Conditions
Brain Metastases
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

RADIOTHERAPY WBRT Patient in supine position Immobilization of the head with a thermoplastic mask Simulation with computed tomography (CT) with contrast. Design: Clinical target volume (CTV): brain and meninges to the foramen magnum Planned treatment volume (PTV): 5 mm from the CTV in all directions...

RADIOTHERAPY WBRT Patient in supine position Immobilization of the head with a thermoplastic mask Simulation with computed tomography (CT) with contrast. Design: Clinical target volume (CTV): brain and meninges to the foramen magnum Planned treatment volume (PTV): 5 mm from the CTV in all directions Planning: Technique: Two latero-lateral fields, with permission to use field inside the fields, known as "field-in-field". Isodose prescription: 95% of the dose covering 95% of PTV Maximum dose allowed in the PTV: 15% higher than the prescribed dose Dose / fractionation: 30 Gy in 10 fractions of 3 Gy once a day, five times a week Treatment Equipment: Linear accelerator of 6-MeV photons (Varian Clinac 600 CD, Varian Medical Systems, Palo Alto, CA, USA) HSRT Planning HSRT Held on the seventh day post-WBRT(or next business day if the date coincides with a weekend or holiday): Patient in supine position Preparation of individualized mask "Mask Patient One set is 41,100 (BrainLAB AG, Heimstetten, Germany) Brain MRI with contrast and volumetric reconstruction of 1 mm without mask and without fiducial markers Brain CT with contrast, 1-mm slices with tracking and stereotactic fixation. Fusion of MRI and CT in the planning system iPlan version 4.1 (BrainLAB AG, Heimstetten, Germany) Delineation Gross tumor volume (GTV): metastasis(es) of the brain displayed in the MRI signal in T1 with contrast Clinical target volume (CTV)= GTV Planning target volume (PTV)= CTV with 3 mm margins in all directions Physical Planning Technique: multiple dynamic arcs, multiple static conformal fields, multiple static modulated fields, multiple static arcs isodose prescription: higher isodose that meets the following criteria: Coverage of at least 95% of the PTV with the prescription dose (V100 ≥ 95%) and 95% Of the prescription dose covering at least 99% of the PTV (V95 ≥ 99%). Maximum dose allowed in or outside the PTV: 20% of prescription dose, while respecting the tolerance of the organs described below. Scores compliance with RTOG Dose escalation scheme Study model It'll be recruited 3 patients to the initial scheme of 4 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 the study 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 next dose level. The same criteria of recruitment will be performed till any scheme reach the MTD or up to the scheme of 4 fractions of 9 Gy. The number of fractions of HSRT will be kept in 4 fractions for all cohorts. The initial dose is 5 Gy per day. Increasing the dose of one cohort to another will be more than 1 Gy per day of HSRT. For example: If the scheme of 4 fractions of 5 Gy will not have unacceptable toxicity, the study continues to recruit patients for the scheme of 4 fractions of 6 Gy, and so subsequently. The study will recruit patients to the fractionation scheme up to four fractions of 9 Gy according to the BEDGy3 be similar to a maximum dose of RS studies to brain metastasis of 24 Gy in one fraction. At the discretion of the responsible investigator for the safety of the study, the number of patients may be increased in each cohort during the study. Restrictions of radiation dose on critical organ optic chiasm: BEDGy3: 90 Gy optic nerves: BEDGy3: 90 Gy optic tract: BEDGy3: 90 Gy brainstem: BEDGy3: 110 Gy retina: BEDGy3: 72 Gy lens: BEDGy3: 16.7 Gy Simulation of HSRT Ten days post-WBRT(or next business day, if the date coincides with a weekend or holiday) Tests of collision safety and quality control testing to ensure the alignment of isocenters radiation, mechanical and coincidence of lasers (Winston-Lutz test). Treatment of HSRT Eleventh day post-WBRT(or next business day, if the date coincides with a weekend or holiday) Treatment equipment linear accelerator of 6-MeV photons (Varian Clinac linear accelerator 600 CD, Varian Medical Systems, Palo Alto, CA, USA) Micromultileaf m3 System(BrainLAB AG, Heimstetten, Germany).

Inclusion Criterias

"Status" of neurological function: zero to 3
Patients with 1-3 brain metastases with histological diagnosis of malignancy and ineligible for surgery or RS
Informed consent for this research signed
...
"Status" of neurological function: zero to 3
Patients with 1-3 brain metastases with histological diagnosis of malignancy and ineligible for surgery or RS
Informed consent for this research signed
Age ≥18 years
Anticipated survival > 3 months
Karnofsky Performance Status (KPS) ≥ 70%

Exclusion Criterias

People with mental incapacity
Inability to have MRI
Indian race
...
People with mental incapacity
Inability to have MRI
Indian race
Prior brain irradiation for any reason
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)
Patients who have undergone prior treatment for specific brain metastases (eg surgery, RS, chemotherapy), excluding corticosteroids
Leptomeningeal dissemination
People in a relationship of dependence as prisoners, soldiers, students, staff, etc..
Primary tumor of lymphoma, leukemia, germ cell, small cell carcinoma or central nervous system

Locations

Barretos, Sao Paulo, 14784-400
Barretos, Sao Paulo, 14784-400

Tracking Information

NCT #
NCT02080949
Collaborators
Not Provided
Investigators
  • Principal Investigator: Ricardo A Nakamura, MD Barretos Cancer Hospital
  • Ricardo A Nakamura, MD Barretos Cancer Hospital