Stereotactic Body Radiotherapy for the Treatment of Solitary Bone Plasmacytoma
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|ClinicalTrials.gov Identifier: NCT03312868|
Recruitment Status : Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : February 9, 2021
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|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Prospective Arm
Prospective arm with patients being treated with SBRT
Stereotactic Body Radiotherapy
- 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
- Local control rate [ Time Frame: 5 years ]Local progression-free survival
- Overall survival [ Time Frame: 5 years ]Overall survival
- 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
- Toxicities [ Time Frame: 5 Years ]Toxicities in the scale of common criteria of toxicity by the National Cancer Institute CTCAE v4
- Quality of Life [ Time Frame: 5 years ]Quality of life of patients in the prospective cohort using the EORTC QLQ-30 questionnaire
- 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
- Dosimetric prognostic factors [ Time Frame: 5 years ]Describe and explore dosimetric factors for local control and toxicities
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 ClinicalTrials.gov identifier (NCT number): NCT03312868
|Sao Paulo Cancer Institute|
|São Paulo, Sao Paulo, Brazil, 01246-000|