NEO-TACTICS trial

Neoadjuvant fractionated stereotactic radiotherapy followed by surgical resection for brain metastases: efficacy and safety study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042220014

Enrollment

Registered

2022-05-02

Start date

2022-06-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain metastase

Interventions

Neoadjuvant stereotactic radiotherapy followed by surgical resection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Distinct number of brain metastases = 2 cm and = 2,000 /mm3, Hb >= 8.0 g/dl, PLT >=10x104 /mm3, AST <= 120 IU/l, ALT <= 120 IU/l, CRE <= 1.5 mg/dl 11. All patients provided written informed consent.

Exclusion criteria

Exclusion criteria: Documented history of active other malignancy Pregnant, breastfeeding, or woman of childbearing age without effective contraception Patient with psychiatric disorder Contraindication to gadolinium injection Emergent surgery needed condition (impending cerebral herniation or acute hydrocephalus)

Design outcomes

Primary

Measure	Time frame
(Surgical site) Local recurrence rate (6 months)	—

Secondary

Measure	Time frame
1. (Surgical site) Radiation necrosis rate (6,12months) 2. (Surgical site) Local recurrence rate (12months) 3. Rate of leptomeningeal dissemination (6,12months) 4. Overall survival 5. Intracranial progression free survival rate (6,12months) 6. Cerebral distant recurrence rate (6,12 months)) 7. Cognitive deteriorate free survival rate (6,12 months) 8. Adverse event rate (pre-operative, post-operative) 9. Exploratory analysis of dosimetric comparison among different modalities	—

Measure

Time frame

1. (Surgical site) Radiation necrosis rate (6,12months) 2. (Surgical site) Local recurrence rate (12months) 3. Rate of leptomeningeal dissemination (6,12months) 4. Overall survival 5. Intracranial progression free survival rate (6,12months) 6. Cerebral distant recurrence rate (6,12 months)) 7. Cognitive deteriorate free survival rate (6,12 months) 8. Adverse event rate (pre-operative, post-operative) 9. Exploratory analysis of dosimetric comparison among different modalities

—

Contacts

Public ContactKazuya Motomura

Shizuoka Cancer Center

k.motomura@scchr.jp+81-55-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026