search
Back to results

Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma

Primary Purpose

Plasmacytoma

Status
Terminated
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
SBRT
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasmacytoma focused on measuring Stereotactic Body Radiotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sao Paulo Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prospective Arm

Arm Description

Prospective arm with patients being treated with SBRT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 12, 2017
Last Updated
March 28, 2022
Sponsor
Instituto do Cancer do Estado de São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT03312868
Brief Title
Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma
Official Title
Phase I/II Trial of Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Burocracy and funding
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmacytoma
Keywords
Stereotactic Body Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective Arm
Arm Type
Experimental
Arm Description
Prospective arm with patients being treated with SBRT
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
Stereotactic Body Radiotherapy
Primary Outcome Measure Information:
Title
Progression-free survival for multiple myeloma
Description
Progression-free survival for multiple myeloma at 5 years evaluation in patients undergoing SBRT for solitary plasmacytoma compared to a retrospective cohort of patients
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Local control rate
Description
Local progression-free survival
Time Frame
5 years
Title
Overall survival
Description
Overall survival
Time Frame
5 years
Title
Survival free of bone events
Description
Those are described as fractures, osteomyelitis, necessity of surgery, deformation of bone or ironic bone pain
Time Frame
5 Years
Title
Toxicities
Description
Toxicities in the scale of common criteria of toxicity by the National Cancer Institute CTCAE v4
Time Frame
5 Years
Title
Quality of Life
Description
Quality of life of patients in the prospective cohort using the EORTC QLQ-30 questionnaire
Time Frame
5 years
Title
Quality of Life
Description
Quality of life of patients in the prospective cohort using the Short Form Health Survey 36 v.2 (SF-36) questionnaire
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Dosimetric prognostic factors
Description
Describe and explore dosimetric factors for local control and toxicities
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sao Paulo Cancer Institute
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6153562
Citation
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.
Results Reference
result
PubMed Identifier
25987031
Citation
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.
Results Reference
result
PubMed Identifier
6780494
Citation
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.
Results Reference
result
PubMed Identifier
16229966
Citation
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.
Results Reference
result
PubMed Identifier
17032388
Citation
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.
Results Reference
result
PubMed Identifier
24773479
Citation
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.
Results Reference
result
PubMed Identifier
18725106
Citation
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.
Results Reference
result

Learn more about this trial

Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma

We'll reach out to this number within 24 hrs