NEO-TACTICS trial

JRCT ID: jRCTs042220014

Registered date:02/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Brain metastase
• Date of first enrollment: 16/06/2022
• Target sample size: 57
• Study type: Interventional

Intervention(s)

Neoadjuvant stereotactic radiotherapy followed
by surgical resection

Outcome(s)

• Primary Outcome: (Surgical site) Local recurrence rate (6 months)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1. Distinct number of brain metastases <= 4, One with surgical indication
2. Index lesion should be >= 2 cm and <= 5 cm in largest dimension, and require resection. Index lesions will be treated with SRS and surgery.
3. All of index lesion exist cerebrum or cerebellar.
4. No radiographic evidence of leptomeningeal disease
5. Eastern Cooperative Oncology Group performance status (ECOG-PS) scores of 0 to 2 and 3 if a result of only neurologic symptoms caused by the tumor.
6. Primary tumors were non-small-cell lung cancer as well as cancers of the breast, colon, kidney, ovary, uterine cervix and corpus, stomach, or esophagus.
7. Primary cancer and/or extra cranial metastases is not progressive critically.
8. Age 20 to 79 years.
9. Patients who have received prior whole brain radiotherapy and/or craniotomy.
10. WBC >= 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.

Exclude 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)

Related Information

• Primary Sponsor: Mitsuya Koichi
• Source(s) of Monetary Support: Accuray Japan K.K.