Intraoperative Hyperthermia for Metastatic Brain Tumors (Phase I/II study)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001308

Enrollment

Registered

2014-12-11

Start date

2010-02-21

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Brain cancer was excised brain metastases in patients having surgery in the treatment of cancer and then underwent hyperthermia during surgery. The high temperature

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Brain metastasis surgery is not possible microscopic complete resection among cancer patients. (2) Brain cancer recurrence after radiotherapy in patients with brain metastasis. (3) Patients with a primary or secondary tumor must be confirmed pathologically. (4) Pathological cancer is adenoma carcinoma, blood cancer, melanoma, sarcoma, tumor to be less than. (5) Karnofsky performance status(KPS) score more than 70 points. (6) 1-3 to be the number of metastatic brain tumors is measured using a magnetic resonance imaging (MRI). (7) age 18-75 (8) Normal hematological, hepatic and renal functions; Total white blood cell count= 3,000/ul, and absolute neutrophil count= 1,500/ul, hemoglobin=8.0 g/dl, platelet count=100,000/ul, Bilirubin=1.2 mg/dl and serum glutamic oxaloacetic transaminase/ serum glutamic-pyruvic transaminase=2.5X ULN (normal 100 mg/dl in National Cancer Center), Serum creatinine=1.5 (9) Study-specific consent form

Exclusion criteria

Exclusion criteria: (1) Brain surgery is possible microscopic complete resection among patients among the cancer patients (2) Uncontrolled primary disease (3) >3 brain lesions or Leptomeningeal seeding (4) Expected survival < 3 months (5) Patients with brain metastases that are not the subject of cancer surgery.(6) If metastases to other organs of the superior vena cava syndrome, spinal cord compression syndrome associated diseases, such as emergency (7) Or are pregnant, or planning a pregnancy, or not to use contraception, and breastfeeding women.

Design outcomes

Primary

Measure	Time frame
decrease for local recurrence rate of metastatic brain tumor	—

Secondary

Measure	Time frame
neurology defecit, quality of life, locak recurrence, overal survival	—

Countries

Korea, Republic of

Contacts

Public ContactYoun JiHye

NCC Hospital

Outcome results