Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma

Phase I/II Trial of Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma

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.

Study Overview

• Status: Terminated
• Conditions: Plasmacytoma
• Intervention / Treatment: Radiation: SBRT

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 in the 1980s and has since been proven to be the best practice in several other comparative trials, mostly retrospective. The radiotherapy dose of curative intent has also been described over the same period and remains unchanged to this day. Thus, local control, disease cure rate, and rate and progression time for multiple myeloma have been unaffected for almost 30 years.

Radiobiology of plasmacytoma cells is also not widely studied. The alpha / beta ratio, which defines the pattern of response of this disease to radiotherapy fractions and its response time, is also not well described. However, it is believed to be smaller in comparison to other hematological malignancies due to reports of cases of intrinsic radioresistance and late recurrence and reports of success with hypofractionated dose in isolated cases where stereotactic techniques were used such as base of skull and spine.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 01246-000
      • Sao Paulo Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prospective Arm; Prospective arm with patients being treated with SBRT	Radiation: SBRT; Stereotactic Body Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	5 years
Local control rate	Local progression-free survival	5 years
Survival free of bone events	Those are described as fractures, osteomyelitis, necessity of surgery, deformation of bone or ironic bone pain	5 Years
Toxicities	Toxicities in the scale of common criteria of toxicity by the National Cancer Institute CTCAE v4	5 Years
Quality of Life	Quality of life of patients in the prospective cohort using the EORTC QLQ-30 questionnaire	5 years
Quality of Life	Quality of life of patients in the prospective cohort using the Short Form Health Survey 36 v.2 (SF-36) questionnaire	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetric prognostic factors	Describe and explore dosimetric factors for local control and toxicities	5 years

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): March 28, 2022
• Study Completion (ACTUAL): March 28, 2022

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (ACTUAL): October 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Stereotactic Body Radiotherapy
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Plasmacytoma
• Other Study ID Numbers: NP 1122/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No