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Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma

Sponsor
Instituto do Cancer do Estado de São Paulo (Other)
Overall Status
Terminated
CT.gov ID
NCT03312868
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
53.8
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 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 :
Oct 1, 2017
Actual Primary Completion Date :
Mar 28, 2022
Actual Study Completion Date :
Mar 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prospective Arm

Prospective arm with patients being treated with SBRT

Radiation: SBRT
Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival for multiple myeloma [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 [5 years]

    Local progression-free survival

  2. Overall survival [5 years]

    Overall survival

  3. Survival free of bone events [5 Years]

    Those are described as fractures, osteomyelitis, necessity of surgery, deformation of bone or ironic bone pain

  4. Toxicities [5 Years]

    Toxicities in the scale of common criteria of toxicity by the National Cancer Institute CTCAE v4

  5. Quality of Life [5 years]

    Quality of life of patients in the prospective cohort using the EORTC QLQ-30 questionnaire

  6. Quality of Life [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 [5 years]

    Describe and explore dosimetric factors for local control and toxicities

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sao Paulo Cancer Institute São Paulo Sao Paulo Brazil 01246-000

Sponsors and Collaborators

  • Instituto do Cancer do Estado de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Geovanne Pedro Mauro, MD, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT03312868
Other Study ID Numbers:
  • NP 1122/17
First Posted:
Oct 18, 2017
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Geovanne Pedro Mauro, MD, Instituto do Cancer do Estado de São Paulo
Stereotactic Body Radiotherapy
Additional relevant MeSH terms:
Plasmacytoma

Study Results

No Results Posted as of Apr 6, 2022