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Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03312868
Recruitment Status : Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : February 9, 2021
Information provided by (Responsible Party):
Geovanne Pedro Mauro, Instituto do Cancer do Estado de São Paulo

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.

Condition or disease Intervention/treatment Phase
Plasmacytoma Radiation: SBRT Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2027
Estimated Study Completion Date : October 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Prospective Arm
Prospective arm with patients being treated with SBRT
Radiation: SBRT
Stereotactic Body Radiotherapy

Primary Outcome Measures :
  1. Progression-free survival for multiple myeloma [ Time Frame: 5 years ]
    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 :
  1. Local control rate [ Time Frame: 5 years ]
    Local progression-free survival

  2. Overall survival [ Time Frame: 5 years ]
    Overall survival

  3. Survival free of bone events [ Time Frame: 5 Years ]
    Those are described as fractures, osteomyelitis, necessity of surgery, deformation of bone or ironic bone pain

  4. Toxicities [ Time Frame: 5 Years ]
    Toxicities in the scale of common criteria of toxicity by the National Cancer Institute CTCAE v4

  5. Quality of Life [ Time Frame: 5 years ]
    Quality of life of patients in the prospective cohort using the EORTC QLQ-30 questionnaire

  6. Quality of Life [ Time Frame: 5 years ]
    Quality of life of patients in the prospective cohort using the Short Form Health Survey 36 v.2 (SF-36) questionnaire

Other Outcome Measures:
  1. Dosimetric prognostic factors [ Time Frame: 5 years ]
    Describe and explore dosimetric factors for local control and toxicities

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03312868

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Sao Paulo Cancer Institute
São Paulo, Sao Paulo, Brazil, 01246-000
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Publications of Results:
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Responsible Party: Geovanne Pedro Mauro, MD, Instituto do Cancer do Estado de São Paulo Identifier: NCT03312868    
Other Study ID Numbers: NP 1122/17
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geovanne Pedro Mauro, Instituto do Cancer do Estado de São Paulo:
Stereotactic Body Radiotherapy
Additional relevant MeSH terms:
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Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases