NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042220014

Registered date:02/05/2022

NEO-TACTICS trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBrain metastase
Date of first enrollment16/06/2022
Target sample size57
Countries of recruitment
Study typeInterventional
Intervention(s)Neoadjuvant stereotactic radiotherapy followed by surgical resection

Outcome(s)

Primary Outcome(Surgical site) Local recurrence rate (6 months)
Secondary Outcome1. (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
GenderBoth
Include criteria1. 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 criteriaDocumented 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

Contact

Public contact
Name Nakamasa Hayashi
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail n.hayashi@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Koichi Mitsuya
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail k.mitsuya@scchr.jp
Affiliation Shizuoka Cancer Center