Status:
TERMINATED
Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Plasmacytoma
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This project aims to propose a new approach in the treatment of solitary plasmacytoma: hypofractionated irradiation alone with stereotactic technique that may contribute to the successful treatment of...
Detailed Description
Solitary plasmacytoma is a rare disease whose treatment has not evolved much in the last decades. The role of radiotherapy in the curative treatment of this entity was defined in a major publication i...
Eligibility Criteria
Inclusion
- Biopsy proven plasmacytic for the index lesion;
- Age between 18 and 85 years;
- ECOG scale performance of 0 to 2
Exclusion
- Refuse to sign or inability to understand the term of free and informed commitment (TCLE);
- Technical limitations for treatment with SBRT among which is cited, but not limited to, weight greater than 115 Kg, inability to abduct limb to be treated in appendicular bone plasmocytomas, intolerable pain to remain in treatment position;
- Criteria for multiple myeloma at diagnosis: more than 10% of plasma cells in bone marrow biopsy, hypercalcemia greater than 11.5 mg/dL, serum creatinine greater than 2mg/dL, creatinine clearance less than 40mL/min , Hemoglobin less than 10g/dL.
- Previous cancer diagnosis and treatments;
- Previous bone events such as fractures and osteomyelitis in the bone in which the index lesion is found;
- Prior autoimmune diseases, even if controlled;
- Extra-medullary plasmacytoma requiring elective treatment of lymph node drainage;
- Current pregnancy
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03312868
Start Date
October 1 2017
End Date
March 28 2022
Last Update
April 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sao Paulo Cancer Institute
São Paulo, São Paulo, Brazil, 01246-000