Targeted radiotherapy for malignant neuroendocrine tumors with MIBG
- Conditions
- Malignant neuroendocrine tumorsmalignant neuroendocrine tumors, I-131 MIBG therapy
- Registration Number
- JPRN-jRCTs041180040
- Lead Sponsor
- Kinuya Seigo
- Brief Summary
Sixty-one patients with malignant neuroendocrine tumors received 100 doses of I-131 MIBG. There were 18 deaths from the primary disease within the study period for the overall survival after treatment. The 5-year estimated survival rate after the first treatment with I-131MIBG was 72%, and the 10-year survival rate was 54%. The predicted survival rate is better than the past reports of standard-dose I-131 MIBG treatment in Japan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 61
1) Patients with histologically proven malignant neuroendocrine tumors
2) Patients with metastases, recurrent lesions or unresectable lesions
3) Positive I131-MIBg uptake
4) Patients with written informed consent
5) Patients with ADL adequate for treatment in an isolation room. Patients with limited ADL which can be compensated by the others under the approval of the ethical board.
1)Pregnant female and feeding female
2)Patients with disturbed consciousness
3)An expected life expectancy of less than 1 month4)Limited bone marrow capacity
Hb<9.0, WBC count<3,000, platelet count <100,000
5)Renal disorder
GFR<30 ml/min/1.73 m2
6)Risks for the central nerve compression syndrome that might be caused by lesion edema during the treatment
7) In case that medical practice and radiation management is difficult in an isolation room, In case of uncontrolled symptoms that require emergent medical cares, In case that urine management is difficult, In case that understanding and cooperation cannot be obtained from family members
8) When medical staffs determine that treatment cannot be properly carried out.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Assessment of anti-tumor effects with tumor size and tumor markers <br>2)Assessment of prognosis<br>3)assessment of symptoms
- Secondary Outcome Measures
Name Time Method Incidence and type of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE v 3.0)<br>1)Bone marrow: hemoglobin, total white blood cell, neutrophils/granulocytes, platelets<br>2)Gastrointestinal (radiation sickness) : appetite loss, nausea, vomiting<br>3)Salivary gland disorder<br>4)Thyroid disorder<br>5)Neurological disorder<br>6)Endocrine disorder: induction of catecholamine excess symptoms