Targeted radiotherapy for malignant neuroendocrine tumors with MIBG

JRCT ID: jRCTs041180040

Registered date:06/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Malignant neuroendocrine tumors
• Date of first enrollment: 14/09/2009
• Target sample size: 100
• Study type: Interventional
• Intervention(s): All patients receive standard or high-dose I-131 MIBG.

Outcome(s)

Primary Outcome

1) Assessment of anti-tumor effects with tumor size and tumor markers
2)Assessment of prognosis
3)assessment of symptoms

Secondary Outcome

Incidence and type of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE v 3.0)
1)Bone marrow: hemoglobin, total white blood cell, neutrophils/granulocytes, platelets
2)Gastrointestinal (radiation sickness) : appetite loss, nausea, vomiting
3)Salivary gland disorder
4)Thyroid disorder
5)Neurological disorder
6)Endocrine disorder: induction of catecholamine excess symptoms

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Kinuya Seigo
• Secondary ID(s): UMIN000002529