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Clinical Trials/JPRN-jRCTs042220014
JPRN-jRCTs042220014
Recruiting
Phase 2

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

Mitsuya Koichi0 sites57 target enrollmentMay 2, 2022
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ConditionsBrain metastase

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Brain metastase
Sponsor
Mitsuya Koichi
Enrollment
57
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 2, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Mitsuya Koichi

Eligibility Criteria

Inclusion 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,

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)

Outcomes

Primary Outcomes

Not specified

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