Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma

NCT03312868 | Terminated Phase 2 DMC

• 1 other identifier: NP 1122/17
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 this disease. This work aims to apply this new technique with the primary objective of reducing the progression-free survival for multiple myeloma of patients treated for solitary plasmacytoma, as well as quantify overall survival, local control, toxicities and quality of life in a phase I trial / II.

Conditions

Plasmacytoma

Keywords

Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival for multiple myeloma

  Progression-free survival for multiple myeloma at 5 years evaluation in patients undergoing SBRT for solitary plasmacytoma compared to a retrospective cohort of patients

  5 years

Secondary Outcomes (6)

• Local control rate

  5 years

• Overall survival

  5 years

• Survival free of bone events

  5 Years

• Toxicities

  5 Years

• Quality of Life

  5 years

Other Outcomes (1)

• Dosimetric prognostic factors

  5 years

Study Arms (1)

Prospective Arm

EXPERIMENTAL

Prospective arm with patients being treated with SBRT

Radiation: SBRT

Interventions

SBRT RADIATION

Stereotactic Body Radiotherapy

Prospective Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven plasmacytic for the index lesion;
• Age between 18 and 85 years;
• ECOG scale performance of 0 to 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Sao Paulo Cancer Institute

São Paulo, São Paulo, 01246-000, Brazil

Location

Related Publications (7)

• Mill WB, Griffith R. The role of radiation therapy in the management of plasma cell tumors. Cancer. 1980 Feb 15;45(4):647-52. doi: 10.1002/1097-0142(19800215)45:43.0.co;2-e.

  PMID: 6153562 RESULT

• Li QW, Niu SQ, Wang HY, Wen G, Li YY, Xia YF, Zhang YJ. Radiotherapy Alone is Associated with Improved Outcomes Over Surgery in the Management of Solitary Plasmacytoma. Asian Pac J Cancer Prev. 2015;16(9):3741-5. doi: 10.7314/apjcp.2015.16.9.3741.

  PMID: 25987031 RESULT

• Mendenhall CM, Thar TL, Million RR. Solitary plasmacytoma of bone and soft tissue. Int J Radiat Oncol Biol Phys. 1980 Nov;6(11):1497-501. doi: 10.1016/0360-3016(80)90006-1. No abstract available.

  PMID: 6780494 RESULT

• Ozsahin M, Tsang RW, Poortmans P, Belkacemi Y, Bolla M, Dincbas FO, Landmann C, Castelain B, Buijsen J, Curschmann J, Kadish SP, Kowalczyk A, Anacak Y, Hammer J, Nguyen TD, Studer G, Cooper R, Sengoz M, Scandolaro L, Zouhair A. Outcomes and patterns of failure in solitary plasmacytoma: a multicenter Rare Cancer Network study of 258 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):210-7. doi: 10.1016/j.ijrobp.2005.06.039. Epub 2005 Oct 17.

  PMID: 16229966 RESULT

• Wong ET, Lu XQ, Devulapalli J, Mahadevan A. Cyberknife radiosurgery for basal skull plasmacytoma. J Neuroimaging. 2006 Oct;16(4):361-3. doi: 10.1111/j.1552-6569.2006.00062.x.

  PMID: 17032388 RESULT

• Chang UK, Lee DH, Kim MS. Stereotactic radiosurgery for primary malignant spinal tumors. Neurol Res. 2014 Jun;36(6):597-606. doi: 10.1179/1743132814Y.0000000381. Epub 2014 Apr 28.

  PMID: 24773479 RESULT

• Timmerman RD. An overview of hypofractionation and introduction to this issue of seminars in radiation oncology. Semin Radiat Oncol. 2008 Oct;18(4):215-22. doi: 10.1016/j.semradonc.2008.04.001. No abstract available.

  PMID: 18725106 RESULT

MeSH Terms

Conditions

Plasmacytoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 18, 2017
• Study Start: October 1, 2017
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)